Trial Outcomes & Findings for Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer (NCT NCT03739684)
NCT ID: NCT03739684
Last Updated: 2021-06-14
Results Overview
The Correct Localization Rate (CLR) will be defined as percentage of participants with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
208 participants
Primary outcome timeframe
Within 60 days following 18F-DCFPyL PET/CT imaging.
Results posted on
2021-06-14
Participant Flow
Participant milestones
| Measure |
18F-DCFPyL Injection
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
|
|---|---|
|
Overall Study
STARTED
|
208
|
|
Overall Study
COMPLETED
|
195
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
Baseline characteristics by cohort
| Measure |
18F-DCFPyL Injection
n=208 Participants
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
|
|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
208 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
188 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other, including not reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 60 days following 18F-DCFPyL PET/CT imaging.Population: Participants who received any amount of 18F-DCFPyL and had a 18F-DCFPyL PET/CT central imaging reader result.
The Correct Localization Rate (CLR) will be defined as percentage of participants with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed.
Outcome measures
| Measure |
18F-DCFPyL Injection
n=208 Participants
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
|
|---|---|
|
Correct Localization Rate (CLR)
Central Reader 1
|
85.6 percentage of participants
Interval 78.8 to 92.3
|
|
Correct Localization Rate (CLR)
Central Reader 2
|
87.0 percentage of participants
Interval 80.4 to 93.6
|
|
Correct Localization Rate (CLR)
Central Reader 3
|
84.8 percentage of participants
Interval 77.8 to 91.9
|
SECONDARY outcome
Timeframe: Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.Population: Participants with a Medical Management Questionnaire (MMQ) completed at pre- and post- 18F-DCFPyL PET/CT imaging.
The change in the intended prostate cancer treatment plan will be based on Medical Management Questionnaires completed prior to and after 18F-DCFPyL PET/CT imaging.
Outcome measures
| Measure |
18F-DCFPyL Injection
n=205 Participants
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
|
|---|---|
|
Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.
|
131 Participants
|
SECONDARY outcome
Timeframe: Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing.Population: The Safety Set includes all participants who received any amount of 18F-DECPyL.
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
Outcome measures
| Measure |
18F-DCFPyL Injection
n=208 Participants
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
|
|---|---|
|
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
Systolic Blood Pressure: Baseline (actual)
|
138.9 mmHg
Standard Deviation 18.61
|
|
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
Systolic Blood Pressure: Post-dosing (actual)
|
136.7 mmHg
Standard Deviation 17.15
|
|
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
Systolic Blood Pressure: Change from Baseline
|
-2.2 mmHg
Standard Deviation 13.24
|
|
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
Diastolic Blood Pressure: Baseline (actual)
|
78.5 mmHg
Standard Deviation 10.18
|
|
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
Diastolic Blood Pressure: Post-dosing (actual)
|
77.3 mmHg
Standard Deviation 9.57
|
|
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
Diastolic Blood Pressure: Change from Baseline
|
-1.2 mmHg
Standard Deviation 8.20
|
SECONDARY outcome
Timeframe: Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing.Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
Outcome measures
| Measure |
18F-DCFPyL Injection
n=208 Participants
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
|
|---|---|
|
The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)
Heart Rate: Baseline (actual)
|
69.3 bpm
Standard Deviation 12.75
|
|
The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)
Heart Rate: Post-dosing (actual)
|
65.1 bpm
Standard Deviation 12.09
|
|
The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)
Heart Rate: Change from Baseline
|
-4.3 bpm
Standard Deviation 7.93
|
SECONDARY outcome
Timeframe: From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.
Medications will be coded using the WHO drug dictionary. The medications are summarized by ATC level 4 category and presented as number and percentage of participants. Results are presented where the percentage of participants within an ATC level 4 category is \>5.0.
Outcome measures
| Measure |
18F-DCFPyL Injection
n=208 Participants
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
|
|---|---|
|
Collection of Concomitant Medications (Safety Outcome Measure)
HMG COA REDUCTASE INHIBITORS
|
103 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
PLATELET AGGREGATION INHIBITORS (EXCLUDING HEPARIN)
|
63 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
ACE INHIBITORS, PLAIN
|
36 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
VITAMIN D AND ANALOGUES
|
32 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
ANGIOTENSIN II ANTAGONISTS, PLAIN
|
31 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
BETA BLOCKING AGENTS, SELECTIVE
|
31 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
DIHYDROPYRIDINE DERIVATIVES
|
31 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
PROTEIN PUMP INHIBITORS
|
29 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
DRUGS USED IN ERECTILE DYSFUNCTION
|
23 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
MULTIVITAMINS, PLAIN
|
18 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
BIGUANIDES
|
17 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
THIAZIDES, PLAIN
|
16 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
OTHER ANTIDEPRESSANTS
|
15 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
ALPHA-ADRENORECEPTOR ANTAGONISTS
|
12 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
PROPIONIC ACID DERIVATIVES
|
12 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
THYROID HORMONES
|
11 Participants
|
|
Collection of Concomitant Medications (Safety Outcome Measure)
UNSPECIFIED HERBAL AND TRADITIONAL MEDICINE
|
11 Participants
|
SECONDARY outcome
Timeframe: From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.
Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.
Outcome measures
| Measure |
18F-DCFPyL Injection
n=208 Participants
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
|
|---|---|
|
Collection of Medical Procedures (Safety Outcome Measure)
Biopsy testes
|
1 Participants
|
|
Collection of Medical Procedures (Safety Outcome Measure)
Computerized tomogram
|
1 Participants
|
|
Collection of Medical Procedures (Safety Outcome Measure)
Nuclear magnetic resonance imaging
|
1 Participants
|
|
Collection of Medical Procedures (Safety Outcome Measure)
Ultrasound testes
|
1 Participants
|
|
Collection of Medical Procedures (Safety Outcome Measure)
Open reduction of fracture
|
1 Participants
|
|
Collection of Medical Procedures (Safety Outcome Measure)
Orchidectomy
|
1 Participants
|
Adverse Events
18F-DCFPyL Injection
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
18F-DCFPyL Injection
n=208 participants at risk
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
|
|---|---|
|
Immune system disorders
Hypersensitivity
|
0.48%
1/208 • Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing.
|
|
Nervous system disorders
Headache
|
0.48%
1/208 • Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing.
|
|
Nervous system disorders
Paresthesia
|
0.48%
1/208 • Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing.
|
Other adverse events
| Measure |
18F-DCFPyL Injection
n=208 participants at risk
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
|
|---|---|
|
Nervous system disorders
Headache
|
1.4%
3/208 • Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing.
|
|
General disorders
Fatigue
|
0.96%
2/208 • Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing.
|
|
Vascular disorders
Hypertension
|
0.96%
2/208 • Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing.
|
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