Trial Outcomes & Findings for 68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer (NCT NCT04716725)
NCT ID: NCT04716725
Last Updated: 2026-05-15
Results Overview
The mean SUVmax and standard deviation across the primary tumor and the 5 largest lesions in each of three metastatic sites (nodal, visceral and osseous; for a maximum of 16 lesions per patient) will be descriptively reported.
TERMINATED
PHASE2
15 participants
Baseline, and up to 16 weeks after initiation of therapy
2026-05-15
Participant Flow
Participant milestones
| Measure |
Experimental (68Ga-PSMA-11 PET)
Patients receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Experimental (68Ga-PSMA-11 PET)
n=15 Participants
Patients receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
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|---|---|
|
Age, Customized
40-49 years old
|
1 Participants
n=11 Participants
|
|
Age, Customized
50-59 years old
|
2 Participants
n=11 Participants
|
|
Age, Customized
60-69 years old
|
2 Participants
n=11 Participants
|
|
Age, Customized
70-79 years old
|
8 Participants
n=11 Participants
|
|
Age, Customized
80-89 years old
|
2 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=11 Participants
|
PRIMARY outcome
Timeframe: Baseline, and up to 16 weeks after initiation of therapyPopulation: Data not collected
The mean SUVmax and standard deviation across the primary tumor and the 5 largest lesions in each of three metastatic sites (nodal, visceral and osseous; for a maximum of 16 lesions per patient) will be descriptively reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, and up to 16 weeks after initiation of therapyPopulation: Data not collected
The median and range of SUVmax across the primary tumor and the 5 largest lesions in each of three metastatic sites (nodal, visceral and osseous; for a maximum of 16 lesions per patient) will be descriptively reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, and up to 16 weeks after initiation of therapyPopulation: Participants were divided into subgroups based on whether or not the participant experienced a \>= 50% decline from baseline in serum PSA
The percent of participants who fall into the PSA50 responders vs. non-responders based on PSMA treatment response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or confirmation by biopsy or correlative imaging within 3 months of PSMA PET.
Outcome measures
| Measure |
Experimental (68Ga-PSMA-11 PET)
n=15 Participants
Participants receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
|
|---|---|
|
Percentage of Participants Who Progressed by Prostate-specific Antigen (PSA) Response Group
PSA Responders who progressed
|
11.1 percentage of participants by group
|
|
Percentage of Participants Who Progressed by Prostate-specific Antigen (PSA) Response Group
PSA Non-Responders who progressed
|
83.3 percentage of participants by group
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SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: The numbers in each row reflect those participants who fall into one of the 2 groups
The study cohort will be dichotomized by participants who fall into the responders vs. non-responders (progressed vs not progressed) based on PSMA PET response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or confirmation by biopsy or correlative imaging within 3 months of PSMA PET. PSA progression-free will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3). The median PFS in months with 95% confidence interval will be reported.
Outcome measures
| Measure |
Experimental (68Ga-PSMA-11 PET)
n=15 Participants
Participants receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
|
|---|---|
|
Progression Free Survival (PFS) by PET Response Group
Not Progressed
|
37.5 months
Interval 12.7 to
There were insufficient number of events so the upper range of the confidence interval could not be calculated
|
|
Progression Free Survival (PFS) by PET Response Group
Progressed
|
5.4 months
Interval 4.4 to 15.2
|
SECONDARY outcome
Timeframe: Baseline, and up to 16 weeks after initiation of therapyPopulation: The numbers in each row reflect those participants who fall into one of the 2 groups
The study cohort will be dichotomized by participants who fall into the responders vs. non-responders (progressed vs not progressed) based on PSMA PET response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or confirmation by biopsy or correlative imaging within 3 months of PSMA PET. PSA progression-free will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3). The percentage of participants who obtained an objective response per Response Evaluation Criteria in Solid Tumors (RECIST) will be reported.
Outcome measures
| Measure |
Experimental (68Ga-PSMA-11 PET)
n=15 Participants
Participants receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
|
|---|---|
|
Objective Response by PET Response Group
Not Progressed
|
33 percentage of participants
|
|
Objective Response by PET Response Group
Progressed
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: The numbers in each row reflect those participants who fall into one of the 2 groups
The study cohort will be dichotomized by participants who fall into the responders vs. non-responders (progressed vs not progressed) based on PSMA PET response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or confirmation by biopsy or correlative imaging within 3 months of PSMA PET. PSA progression-free will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3). The median OS and 95% confidence interval will be reported.
Outcome measures
| Measure |
Experimental (68Ga-PSMA-11 PET)
n=15 Participants
Participants receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
|
|---|---|
|
Overall Survival (OS) by PET Response Group
Not Progressed
|
NA months
There were insufficient number of events for PSA responders so a median and confidence interval could not be calculated
|
|
Overall Survival (OS) by PET Response Group
Progressed
|
33.3 months
Interval 17.6 to 36.6
|
Adverse Events
Experimental (68Ga-PSMA-11 PET)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ivan de Kouchkovsky, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place