Trial Outcomes & Findings for Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence (NCT NCT03353740)

NCT ID: NCT03353740

Last Updated: 2021-10-21

Results Overview

The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 346 participants
• Primary outcome timeframe: 1 Day
• Results posted on: 2021-10-21

Participant Flow

Participant milestones

Measure	Ga-68 Labeled PSMA-11 PET PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Overall Study STARTED	346
Overall Study COMPLETED	294
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Measure

Ga-68 Labeled PSMA-11 PET PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

Overall Study Images for these participants not viable

52

Baseline Characteristics

Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence

Baseline characteristics by cohort

Measure	Ga-68 Labeled PSMA-11 PET n=346 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Age, Customized 40-49 years old	2 Participants n=5 Participants
Age, Customized 50-59 years old	22 Participants n=5 Participants
Age, Customized 60-69 years old	125 Participants n=5 Participants
Age, Customized 70-79 years old	157 Participants n=5 Participants
Age, Customized 80-89 years old	40 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	346 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	323 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	276 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	40 Participants n=5 Participants
Region of Enrollment United States	346 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Population: Data on clinical and conventional imaging follow-up not collected

The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 Day

Population: Data on clinical and conventional imaging follow-up not collected

The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 Day

Population: Data on clinical and conventional imaging follow-up not collected

The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 day

Population: Data on clinical and conventional imaging follow-up not collected

The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Population: Data on clinical and conventional imaging follow-up not collected

Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Population: Data on clinical and conventional imaging follow-up not collected

Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in visceral tissue as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Population: Data on clinical and conventional imaging follow-up not collected

Positive predictive value is the probability that participants with a positive reading truly have prostate cancer metastasized in the bone as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Population: Data on clinical and conventional imaging follow-up not collected

Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Population: Only 7 participants had adequate histology/biopsy data for this analysis

The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.

Outcome measures

Measure

Ga-68 Labeled PSMA-11 PET n=7 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only

0.40 proportion of participants

SECONDARY outcome

Timeframe: 1 Day

Population: Only 9 participants had adequate histology/biopsy data for this analysis

The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.

Outcome measures

Measure

Ga-68 Labeled PSMA-11 PET n=9 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only

0.86 proportion of participants

SECONDARY outcome

Timeframe: 1 Day

Population: Only 2 participants had adequate histology/biopsy data for this analysis

The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.

Outcome measures

Measure

Ga-68 Labeled PSMA-11 PET n=2 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only

1.00 proportion of participants

SECONDARY outcome

Timeframe: 1 Day

Population: Only 30 participants had adequate histology/biopsy data for this analysis

The true positive rate or detection rate is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.

Outcome measures

Measure

Ga-68 Labeled PSMA-11 PET n=30 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only

0.88 proportion of participants

SECONDARY outcome

Timeframe: 1 Day

Population: Only 7 participants had adequate histology/biopsy data for this analysis

Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy

Outcome measures

Measure

Ga-68 Labeled PSMA-11 PET n=7 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only

0.5 proportion

SECONDARY outcome

Timeframe: 1 Day

Population: Only 9 participants had adequate histology/biopsy data for this analysis

Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the visceral tissue as confirmed by by histopathology/biopsy

Outcome measures

Measure

Ga-68 Labeled PSMA-11 PET n=9 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only

0.86 proportion

SECONDARY outcome

Timeframe: 1 Day

Population: Only 2 participants had adequate histology/biopsy data for this analysis

Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the bone tissue as confirmed by by histopathology/biopsy

Outcome measures

Measure

Ga-68 Labeled PSMA-11 PET n=2 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only

1.00 proportion

SECONDARY outcome

Timeframe: 1 Day

Population: Only 30 participants had adequate histology/biopsy data for this analysis

Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy

Outcome measures

Measure

Ga-68 Labeled PSMA-11 PET n=30 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only

0.92 proportion

SECONDARY outcome

Timeframe: 1 Day

Population: The number analyzed per row represents the number of participants in each category

Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA value (0.2- <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, >=5.0) will be summarized in tabular format for participants with PSMA positive disease, independent of pathology, imaging or clinical follow-up.

Outcome measures

Measure	Ga-68 Labeled PSMA-11 PET n=294 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value PSA = < 0.5	0.53 proportion of participants
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value PSA = 0.5 - <1.0	0.68 proportion of participants
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value PSA = 1.0 - <2.0	0.68 proportion of participants
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value PSA = 2.0 - <5.0	0.93 proportion of participants
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value PSA >= 5.0	0.94 proportion of participants

SECONDARY outcome

Timeframe: 1 Day

Population: Prior cancer treatment for only 287 evaluable participants was collected. The number analyzed per row represents the number of participants in each category.

Detection rates (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior cancer treatment (Prostatectomy, Radiation, or Prostatectomy plus Radiation) will be summarized in tabular format.

Outcome measures

Measure	Ga-68 Labeled PSMA-11 PET n=287 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment Prostatectomy only	0.93 proportion of participants
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment Radiation therapy only	0.65 proportion of participants
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment Prostatectomy and salvage radiation therapy	0.84 proportion of participants

SECONDARY outcome

Timeframe: 1 Day

Population: Prior ADT treatment for only 272 evaluable participants was collected. The number analyzed per row represents the number of participants in each category.

Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior use of ADT as a cancer treatment (Prior treatment with ADT, No prior treatment with ADT) will be summarized in tabular format.

Outcome measures

Measure	Ga-68 Labeled PSMA-11 PET n=272 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT) Prior treatment with ADT	0.8 proportion of participants
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT) No prior treatment with ADT	0.8 proportion of participants

SECONDARY outcome

Timeframe: Up to 6 months

Population: Data on change in clinical management not collected for this sample

Impact of 68Ga-PSMA-11 PET on clinical management in patients with biochemical recurrence (BCR) was measured using Pre-PET (Q1), post-PET (Q2), and post-treatment (Q3) questionnaires sent to referring physicians recording site of recurrence and intended (Q1 to Q2 change) and implemented (Q3) therapeutic and diagnostic management. Percentage of participants with a change in clinical management will be reported using descriptive statistics based on qualitative physician responses from the change in management surveys.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Population: Inter-reader reproducibility data not collected

Inter-reader reproducibility for positivity at the patient level will be reported using the Fleiss' Kappa test for multiple readers

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days

All grade 3 and above adverse events will be recorded using the NCI CTCAE v4.0. The Investigator will assign attribution of the possible association of the event with use of the investigational drug.

Outcome measures

Measure

Ga-68 Labeled PSMA-11 PET n=346 Participants PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events

0 Participants

Adverse Events

Ga-68 Labeled PSMA-11 PET

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thomas Hope, MD

University of California, San Francisco

Phone: (415) 221-4810

Email: thomas.hope@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place