Trial Outcomes & Findings for Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer (NCT NCT02981368)

Last Updated: 2021-08-09

Results Overview

The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

385 participants

Primary outcome timeframe

Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Results posted on

2021-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	High Risk Prostate Cancer (Cohort A) Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Recurrent or Metastatic Prostate Cancer (Cohort B) Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
Overall Study STARTED	268	117
Overall Study COMPLETED	248	102
Overall Study NOT COMPLETED	20	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Risk Prostate Cancer (Cohort A) n=268 Participants Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Recurrent or Metastatic Prostate Cancer (Cohort B) n=117 Participants Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Total n=385 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	68 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	268 Participants n=5 Participants	117 Participants n=7 Participants	385 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	233 Participants n=5 Participants	101 Participants n=7 Participants	334 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	23 Participants n=5 Participants	6 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Population: The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=252 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) Central Reader 1	97.9 percentage of participants Interval 94.52 to 99.37	—	—	—	—	—	—	—
Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) Central Reader 2	98.9 percentage of participants Interval 96.0 to 99.96	—	—	—	—	—	—	—
Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) Central Reader 3	96.3 percentage of participants Interval 93.64 to 98.99	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=252 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) Central Reader 1	41.9 percentage of participants Interval 29.65 to 54.22	—	—	—	—	—	—	—
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) Central Reader 2	30.6 percentage of participants Interval 19.17 to 42.12	—	—	—	—	—	—	—
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) Central Reader 3	40.3 percentage of participants Interval 28.11 to 52.53	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).

Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.

Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=268 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low n=117 Participants Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal n=268 Participants Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal n=117 Participants Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High n=268 Participants Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High n=117 Participants Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing n=268 Participants Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing n=117 Participants Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Platelets · Cohort B - Baseline Value: Normal	0 Participants	3 Participants	0 Participants	70 Participants	0 Participants	0 Participants	0 Participants	29 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hematocrit · Cohort A - Baseline Value: Low	26 Participants	0 Participants	12 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hematocrit · Cohort B - Baseline Value: Low	0 Participants	31 Participants	0 Participants	6 Participants	0 Participants	0 Participants	0 Participants	10 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hematocrit · Cohort A - Baseline Value: Normal	29 Participants	0 Participants	179 Participants	0 Participants	1 Participants	0 Participants	12 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hematocrit · Cohort B - Baseline Value: Normal	0 Participants	1 Participants	0 Participants	47 Participants	0 Participants	0 Participants	0 Participants	22 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hematocrit · Cohort A - Baseline Value: High	0 Participants	0 Participants	4 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hematocrit · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hematocrit · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hematocrit · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hemoglobin · Cohort A - Baseline Value: Low	16 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hemoglobin · Cohort B - Baseline Value: Low	0 Participants	33 Participants	0 Participants	6 Participants	0 Participants	0 Participants	0 Participants	13 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hemoglobin · Cohort A - Baseline Value: Normal	18 Participants	0 Participants	210 Participants	0 Participants	1 Participants	0 Participants	11 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hemoglobin · Cohort B - Baseline Value: Normal	0 Participants	2 Participants	0 Participants	43 Participants	0 Participants	0 Participants	0 Participants	18 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hemoglobin · Cohort A - Baseline Value: High	0 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hemoglobin · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hemoglobin · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Hemoglobin · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Platelets · Cohort A - Baseline Value: Low	12 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Platelets · Cohort B - Baseline Value: Low	0 Participants	9 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Platelets · Cohort A - Baseline Value: Normal	4 Participants	0 Participants	230 Participants	0 Participants	1 Participants	0 Participants	13 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Platelets · Cohort A - Baseline Value: High	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Platelets · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Platelets · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Platelets · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Erythrocytes · Cohort A - Baseline Value: Low	29 Participants	0 Participants	8 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Erythrocytes · Cohort B - Baseline Value: Low	0 Participants	36 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	10 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Erythrocytes · Cohort A - Baseline Value: Normal	20 Participants	0 Participants	194 Participants	0 Participants	0 Participants	0 Participants	11 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Erythrocytes · Cohort B - Baseline Value: Normal	0 Participants	6 Participants	0 Participants	39 Participants	0 Participants	0 Participants	0 Participants	22 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Erythrocytes · Cohort A - Baseline Value: High	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Erythrocytes · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Erythrocytes · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Erythrocytes · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Leukocytes · Cohort A - Baseline Value: Low	7 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Leukocytes · Cohort B - Baseline Value: Low	0 Participants	7 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Leukocytes · Cohort A - Baseline Value: Normal	4 Participants	0 Participants	208 Participants	0 Participants	18 Participants	0 Participants	12 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Leukocytes · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Leukocytes · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Leukocytes · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Leukocytes · Cohort B - Baseline Value: Normal	0 Participants	0 Participants	0 Participants	71 Participants	0 Participants	1 Participants	0 Participants	30 Participants
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) Leukocytes · Cohort A - Baseline Value: High	0 Participants	0 Participants	7 Participants	0 Participants	5 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).

Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.

Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=268 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low n=117 Participants Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal n=268 Participants Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal n=117 Participants Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High n=268 Participants Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High n=117 Participants Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing n=268 Participants Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing n=117 Participants Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Urea Nitrogen · Cohort B - Baseline Value: Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alkaline Phosphatase · Cohort B - Baseline Value: Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alkaline Phosphatase · Cohort A - Baseline Value: Normal	5 Participants	0 Participants	210 Participants	0 Participants	0 Participants	0 Participants	38 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alkaline Phosphatase · Cohort B - Baseline Value: Normal	0 Participants	0 Participants	0 Participants	61 Participants	0 Participants	4 Participants	0 Participants	35 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alkaline Phosphatase · Cohort A - Baseline Value: High	0 Participants	0 Participants	4 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alkaline Phosphatase · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alkaline Phosphatase · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alanine Aminotransferase · Cohort A - Baseline Value: Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alanine Aminotransferase · Cohort B - Baseline Value: Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alanine Aminotransferase · Cohort A - Baseline Value: Normal	0 Participants	0 Participants	197 Participants	0 Participants	7 Participants	0 Participants	35 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Aspartate Aminotransferase · Cohort A - Baseline Value: High	0 Participants	0 Participants	4 Participants	0 Participants	8 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alanine Aminotransferase · Cohort B - Baseline Value: Normal	0 Participants	1 Participants	0 Participants	67 Participants	0 Participants	2 Participants	0 Participants	42 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alanine Aminotransferase · Cohort A - Baseline Value: High	0 Participants	0 Participants	9 Participants	0 Participants	14 Participants	0 Participants	4 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alanine Aminotransferase · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants	0 Participants	1 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alanine Aminotransferase · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Potassium · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Aspartate Aminotransferase · Cohort A - Baseline Value: Low	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Aspartate Aminotransferase · Cohort B - Baseline Value: Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Urea Nitrogen · Cohort A - Baseline Value: Low	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Aspartate Aminotransferase · Cohort A - Baseline Value: Normal	8 Participants	0 Participants	193 Participants	0 Participants	4 Participants	0 Participants	43 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Aspartate Aminotransferase · Cohort B - Baseline Value: Normal	0 Participants	0 Participants	0 Participants	60 Participants	0 Participants	4 Participants	0 Participants	45 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Aspartate Aminotransferase · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	5 Participants	0 Participants	1 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Aspartate Aminotransferase · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Aspartate Aminotransferase · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Bilirubin · Cohort A - Baseline Value: Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Bilirubin · Cohort B - Baseline Value: Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Bilirubin · Cohort A - Baseline Value: Normal	1 Participants	0 Participants	194 Participants	0 Participants	22 Participants	0 Participants	33 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Bilirubin · Cohort B - Baseline Value: Normal	0 Participants	0 Participants	0 Participants	69 Participants	0 Participants	2 Participants	0 Participants	41 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Bilirubin · Cohort A - Baseline Value: High	0 Participants	0 Participants	5 Participants	0 Participants	6 Participants	0 Participants	5 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Bilirubin · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Bilirubin · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Bilirubin · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Calcium · Cohort A - Baseline Value: Low	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Calcium · Cohort B - Baseline Value: Low	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Calcium · Cohort A - Baseline Value: Normal	25 Participants	0 Participants	219 Participants	0 Participants	0 Participants	0 Participants	18 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Calcium · Cohort B - Baseline Value: Normal	0 Participants	1 Participants	0 Participants	81 Participants	0 Participants	0 Participants	0 Participants	32 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Calcium · Cohort A - Baseline Value: High	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Calcium · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Calcium · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Calcium · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Creatinine · Cohort A - Baseline Value: Low	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Creatinine · Cohort B - Baseline Value: Low	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Creatinine · Cohort B - Baseline Value: Normal	0 Participants	2 Participants	0 Participants	66 Participants	0 Participants	2 Participants	0 Participants	32 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Creatinine · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	6 Participants	0 Participants	1 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Creatinine · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Creatinine · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Glucose · Cohort A - Baseline Value: Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Glucose · Cohort B - Baseline Value: Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Glucose · Cohort A - Baseline Value: Normal	0 Participants	0 Participants	155 Participants	0 Participants	19 Participants	0 Participants	9 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Glucose · Cohort B - Baseline Value: Normal	0 Participants	2 Participants	0 Participants	25 Participants	0 Participants	14 Participants	0 Participants	16 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Glucose · Cohort A - Baseline Value: High	0 Participants	0 Participants	20 Participants	0 Participants	53 Participants	0 Participants	7 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Glucose · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	13 Participants	0 Participants	29 Participants	0 Participants	17 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Glucose · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Glucose · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Potassium · Cohort A - Baseline Value: Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Potassium · Cohort B - Baseline Value: Low	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Potassium · Cohort A - Baseline Value: Normal	5 Participants	0 Participants	226 Participants	0 Participants	7 Participants	0 Participants	18 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Potassium · Cohort B - Baseline Value: Normal	0 Participants	2 Participants	0 Participants	75 Participants	0 Participants	0 Participants	0 Participants	35 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Potassium · Cohort A - Baseline Value: High	0 Participants	0 Participants	7 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Potassium · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Potassium · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	4 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Urea Nitrogen · Cohort A - Baseline Value: Normal	1 Participants	0 Participants	222 Participants	0 Participants	8 Participants	0 Participants	12 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Urea Nitrogen · Cohort A - Baseline Value: High	0 Participants	0 Participants	11 Participants	0 Participants	7 Participants	0 Participants	2 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Urea Nitrogen · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	4 Participants	0 Participants	16 Participants	0 Participants	10 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Urea Nitrogen · Cohort A - Baseline Value: Missing	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Urea Nitrogen · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alanine Aminotransferase · Cohort B - Baseline Value: Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Creatinine · Cohort A - Baseline Value: Normal	1 Participants	0 Participants	223 Participants	0 Participants	9 Participants	0 Participants	15 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Creatinine · Cohort A - Baseline Value: High	0 Participants	0 Participants	4 Participants	0 Participants	8 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Urea Nitrogen · Cohort B - Baseline Value: Normal	0 Participants	0 Participants	0 Participants	54 Participants	0 Participants	8 Participants	0 Participants	25 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alkaline Phosphatase · Cohort A - Baseline Value: Low	3 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) Alkaline Phosphatase · Cohort B - Baseline Value: High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	9 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Changes in ECG pre-drug dosing and within 1-2 hours post-dosing

Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing ECG measurements).

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=260 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low n=264 Participants Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal n=114 Participants Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal n=115 Participants Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) Normal ECG Evaluation	159 Participants	155 Participants	55 Participants	51 Participants	—	—	—	—
Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) Abnormal ECG Evaluation	101 Participants	109 Participants	59 Participants	64 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.

Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=268 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low n=117 Participants Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) Systolic Blood Pressure: Post-dosing (Actual)	133.7 mm Hg Standard Deviation 16.57	132.1 mm Hg Standard Deviation 19.11	—	—	—	—	—	—
Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) Systolic Blood Pressure: Change from Baseline	0.1 mm Hg Standard Deviation 12.30	-1.3 mm Hg Standard Deviation 11.57	—	—	—	—	—	—
Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) Diastolic Blood Pressure: Baseline (Actual)	79.3 mm Hg Standard Deviation 8.62	77.2 mm Hg Standard Deviation 10.16	—	—	—	—	—	—
Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) Diastolic Blood Pressure: Post-dosing (Actual)	78.5 mm Hg Standard Deviation 9.12	76.4 mm Hg Standard Deviation 9.02	—	—	—	—	—	—
Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) Diastolic Blood Pressure: Change from Baseline	-0.7 mm Hg Standard Deviation 7.04	-0.7 mm Hg Standard Deviation 8.18	—	—	—	—	—	—
Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) Systolic Blood Pressure: Baseline (Actual)	133.7 mm Hg Standard Deviation 15.99	133.6 mm Hg Standard Deviation 19.00	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.

Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=268 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low n=117 Participants Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) Heart Rate: Baseline (Actual)	70.7 beats per minute Standard Deviation 12.03	71.3 beats per minute Standard Deviation 12.94	—	—	—	—	—	—
Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) Heart Rate: Post-dosing (Actual)	66.4 beats per minute Standard Deviation 10.98	67.0 beats per minute Standard Deviation 11.23	—	—	—	—	—	—
Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) Heart Rate: Change from Baseline	-4.4 beats per minute Standard Deviation 6.88	-4.6 beats per minute Standard Deviation 6.53	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.

Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=265 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low n=117 Participants Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) Respiration Rate: Post-dosing (Actual)	16.6 breaths per minute Standard Deviation 3.32	17.3 breaths per minute Standard Deviation 2.28	—	—	—	—	—	—
Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) Respiration Rate: Change from Baseline	-0.1 breaths per minute Standard Deviation 2.03	0.0 breaths per minute Standard Deviation 2.00	—	—	—	—	—	—
Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) Respiration Rate: Baseline (Actual)	16.7 breaths per minute Standard Deviation 3.33	17.3 breaths per minute Standard Deviation 2.16	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.

Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=266 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low n=117 Participants Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) Temperature: Baseline (Actual)	36.58 degrees Celsius Standard Deviation 0.433	36.56 degrees Celsius Standard Deviation 0.338	—	—	—	—	—	—
Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) Temperature: Post-dosing (Actual)	36.50 degrees Celsius Standard Deviation 0.479	36.59 degrees Celsius Standard Deviation 0.309	—	—	—	—	—	—
Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) Temperature: Change from Baseline	-0.08 degrees Celsius Standard Deviation 0.496	0.03 degrees Celsius Standard Deviation 0.265	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.

Population: Participants with recurrent or metastatic prostate cancer who received 18F-DCFPyL, underwent a conventional image-guided biopsy, and provided an 18F-DCFPyL PET/CT image result and a corresponding histopathology result, along with a conventional image that confirmed the location of the histopathology sample.

Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=93 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) Central Reader 1	98.6 percentage of participants Interval 91.6 to 100.0	—	—	—	—	—	—	—
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) Central Reader 2	95.8 percentage of participants Interval 87.81 to 99.04	—	—	—	—	—	—	—
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) Central Reader 3	92.9 percentage of participants Interval 83.98 to 97.28	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken

Population: The Evaluable Set consisted of high risk cancer participants (Cohort A) who received 18F-DCFPyL and had a prostatectomy or lymphadenectomy, and participants with recurrent or metastatic prostate cancer (Cohort B) who received 18F-DCFPyL and had a conventional image-guided biopsy, and had an 18F-DCFPyL PET/CT imaging result and a corresponding histology result.

The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=252 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low n=252 Participants Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal n=252 Participants Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal n=252 Participants Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High n=92 Participants Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High n=93 Participants Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing n=93 Participants Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing n=93 Participants Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Bone · Number of Lesions: 0	239 Participants	234 Participants	247 Participants	237 Participants	37 Participants	22 Participants	28 Participants	23 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Bone · Number of Lesions: 1-2	9 Participants	17 Participants	4 Participants	13 Participants	20 Participants	21 Participants	24 Participants	22 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Bone · Number of Lesions: 5-6	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	5 Participants	2 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Bone · Number of Lesions: >6	1 Participants	0 Participants	0 Participants	0 Participants	26 Participants	37 Participants	32 Participants	36 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Visceral/Soft Tissue · Number of Lesions: 0	233 Participants	241 Participants	249 Participants	240 Participants	72 Participants	71 Participants	73 Participants	64 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Visceral/Soft Tissue · Number of Lesions: 1-2	16 Participants	11 Participants	3 Participants	12 Participants	13 Participants	15 Participants	14 Participants	20 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Visceral/Soft Tissue · Number of Lesions: 3-4	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants	1 Participants	4 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Visceral/Soft Tissue · Number of Lesions: 5-6	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Visceral/Soft Tissue · Number of Lesions: >6	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	4 Participants	3 Participants	5 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Lymph Nodes · Number of Lesions: 0	157 Participants	216 Participants	226 Participants	218 Participants	37 Participants	38 Participants	37 Participants	38 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Lymph Nodes · Number of Lesions: 1-2	39 Participants	28 Participants	19 Participants	25 Participants	18 Participants	11 Participants	16 Participants	10 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Lymph Nodes · Number of Lesions: 3-4	10 Participants	5 Participants	4 Participants	5 Participants	8 Participants	7 Participants	13 Participants	10 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Lymph Nodes · Number of Lesions: >6	29 Participants	0 Participants	0 Participants	1 Participants	22 Participants	29 Participants	23 Participants	27 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Prostate Gland · Number of Lesions: 0	162 Participants	5 Participants	5 Participants	14 Participants	79 Participants	64 Participants	69 Participants	63 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Prostate Gland · Number of Lesions: 1-2	88 Participants	199 Participants	209 Participants	204 Participants	12 Participants	20 Participants	22 Participants	30 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Prostate Gland · Number of Lesions: 3-4	0 Participants	38 Participants	33 Participants	31 Participants	0 Participants	6 Participants	1 Participants	0 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Prostate Gland · Number of Lesions: 5-6	0 Participants	10 Participants	4 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Prostate Gland · Number of Lesions: >6	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: All · Number of Lesions: 0	109 Participants	3 Participants	5 Participants	14 Participants	14 Participants	3 Participants	11 Participants	7 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: All · Number of Lesions: 1-2	75 Participants	174 Participants	196 Participants	175 Participants	11 Participants	15 Participants	17 Participants	14 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: All · Number of Lesions: 3-4	16 Participants	55 Participants	38 Participants	47 Participants	8 Participants	10 Participants	9 Participants	8 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: All · Number of Lesions: 5-6	17 Participants	9 Participants	10 Participants	11 Participants	9 Participants	9 Participants	10 Participants	11 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: All · Number of Lesions: >6	35 Participants	11 Participants	3 Participants	5 Participants	50 Participants	56 Participants	46 Participants	53 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Bone · Number of Lesions: 3-4	0 Participants	1 Participants	1 Participants	2 Participants	8 Participants	10 Participants	4 Participants	10 Participants
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Tissue Site: Lymph Nodes · Number of Lesions: 5-6	16 Participants	3 Participants	3 Participants	3 Participants	7 Participants	8 Participants	4 Participants	8 Participants

SECONDARY outcome

Timeframe: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Population: The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and had a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.

Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=247 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) Central Reader 2	100.0 percentage of participants Interval 98.1 to 100.0	—	—	—	—	—	—	—
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) Central Reader 1	100.0 percentage of participants Interval 98.1 to 100.0	—	—	—	—	—	—	—
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) Central Reader 3	100.0 percentage of participants Interval 98.1 to 100.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=247 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) Central Reader 1	0 percentage of participants NPV was 0 - no participant had negative histology in the prostate.	—	—	—	—	—	—	—
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) Central Reader 2	0 percentage of participants NPV was 0 - no participant had negative histology in the prostate.	—	—	—	—	—	—	—
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) Central Reader 3	0 percentage of participants NPV was 0 - no participant had negative histology in the prostate.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=252 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) Central Reader 2	90.5 percentage of participants Interval 69.9 to 98.6	—	—	—	—	—	—	—
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) Central Reader 1	86.7 percentage of participants Interval 69.7 to 95.3	—	—	—	—	—	—	—
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) Central Reader 3	78.1 percentage of participants Interval 63.8 to 92.5	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=252 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) Central Reader 1	83.8 percentage of participants Interval 78.9 to 88.6	—	—	—	—	—	—	—
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) Central Reader 2	81.4 percentage of participants Interval 76.4 to 86.4	—	—	—	—	—	—	—
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) Central Reader 3	83.2 percentage of participants Interval 78.2 to 88.1	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.

Population: The Evaluable Set consisted of participants in Cohort B who received 18F-DCFPyl, had an 18F-DCFPyL PET/CT imaging result, had a conventional image-guided biopsy and a corresponding histology result.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=93 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) Central Reader 2	81.9 percentage of participants Interval 73.7 to 90.2	—	—	—	—	—	—	—
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) Central Reader 3	87.8 percentage of participants Interval 80.4 to 95.3	—	—	—	—	—	—	—
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) Central Reader 1	81.2 percentage of participants Interval 72.9 to 89.5	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.

Population: Ten (10) participants from a single investigational site with high risk localized prostate cancer scheduled to undergo radical prostatectomy with pelvic lymph node dissection (Cohort A) agreed and were consented to participate in the PK portion of the study.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=10 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants	0.43 µCi/mL Standard Deviation 0.088	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.

Outcome measures

Outcome measures
Measure	High Risk Prostate Cancer (Cohort A) n=10 Participants High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Cohort B - Follow-up Value: Low Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Normal Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value Normal Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: High Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: High Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.	Cohort A - Follow-up Value: Missing Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.	Cohort B - Follow-up Value: Missing Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants	0.82 h*μCi/ml Standard Deviation 0.143	—	—	—	—	—	—	—

Adverse Events

High Risk Prostate Cancer (Cohort A)

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Recurrent or Metastatic Prostate Cancer (Cohort B)

Serious events: 6 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High Risk Prostate Cancer (Cohort A) n=268 participants at risk Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Recurrent or Metastatic Prostate Cancer (Cohort B) n=117 participants at risk Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
Cardiac disorders coronary artery disease	0.37% 1/268 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.	0.85% 1/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.
Cardiac disorders atrial fibrillation	0.00% 0/268 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.	0.85% 1/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.
Gastrointestinal disorders Lower gastrointestinal haemmorhage	0.00% 0/268 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.	0.85% 1/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.
Infections and infestations pyelonephritis, acute	0.00% 0/268 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.	0.85% 1/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.
Metabolism and nutrition disorders hyperkalaemia	0.00% 0/268 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.	0.85% 1/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.
Nervous system disorders spinal cord compression	0.00% 0/268 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.	0.85% 1/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.

Other adverse events

Other adverse events
Measure	High Risk Prostate Cancer (Cohort A) n=268 participants at risk Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	Recurrent or Metastatic Prostate Cancer (Cohort B) n=117 participants at risk Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
Nervous system disorders dysgeusia	3.4% 9/268 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.	0.85% 1/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.
Nervous system disorders headache	3.4% 9/268 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.	0.00% 0/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.
General disorders fatigue	1.9% 5/268 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.	0.00% 0/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.
Gastrointestinal disorders diarrhea	1.1% 3/268 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.	0.00% 0/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.

Additional Information

David Myl

Lantheus Medical Imaging / Progenics Pharmaceuticals

Phone: 914-582-1120

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Study results cannot be published before the earlier of a multi-site publication; or 18 months after the end of the Study at all sites; or confirmation by Sponsor that there will be no multi-site publication. The proposed publication must be submitted to Sponsor at least 60 days prior to publication so that Sponsor can delete Sponsor Confidential Information (other than Study results) and obtain a further 60 days to file on any invention disclosed in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER