68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04716725|
Recruitment Status : Not yet recruiting
First Posted : January 20, 2021
Last Update Posted : May 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8||Drug: 68Ga-PSMA-11 Procedure: Positron Emission Tomography (PET)||Phase 2|
I. To determine whether the percent change from baseline to 16 weeks (+/- 8 weeks) in maximum standard uptake value (SUVmax) averaged across up to 20 lesions per patient (SUVmax-average [ave]) is associated with >= 50% decline from baseline in serum prostate specific antigen (PSA50) response.
I. To determine whether the percent change from baseline in SUVmax-ave on PSMA PET is associated with time-to-event endpoints including PSA progression-free survival by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria, radiographic progression-free survival by PCWG3 criteria, and overall survival.
II. To determine whether the percent change from baseline in SUVmax on PSMA PET is associated with objective response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 on a per-lesion basis among measurable soft tissue lesions present at baseline.
EXPLORATORY (CORRELATIVE) OBJECTIVES:
I. To descriptively characterize the histologic, transcriptional, and genomic features of PSMA low/negative lesions among patients who undergo paired optional metastatic tumor biopsy.
II. To descriptively characterize the relationship between SUVmax-ave on baseline Ga-PSMA PET with optional baseline fludeoxyglucose F-18 (FDG)-PET.
III. To determine whether heterogeneity of PSMA expression on baseline Ga-PSMA PET is associated with overall survival.
IV. To descriptively characterize the patterns of PSMA expression at the time of disease progression among patients who undergo optional PSMA PET.
V. To determine whether the percent change from baseline in PSMA PET is associated with PSA50 response among subgroups of patients defined by treatment modality received, including androgen receptor (AR) targeting treatment, PSMA-targeting radioligand therapy, cytotoxic chemotherapy, and immunotherapy.
Patients receive gallium Ga 68-PSMA-11 intravenously (IV) and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
After progression or study completion, patients are followed up every 3 months for up to 24 months
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of 68Ga-PSMA-11 PET in Patients With Metastatic Castration Resistant Prostate Cancer|
|Estimated Study Start Date :||July 31, 2021|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: 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.
Procedure: Positron Emission Tomography (PET)
- Comparison between mean percent change in maximum standard uptake value (SUVmax) with Prostate-specific antigen (PSA) response group [ Time Frame: Baseline, and up to 16 weeks after initiation of therapy ]The study cohort will be divided into subgroups based on whether or not patient experienced a >= 50% decline from baseline in serum PSA (PSA50 responder) or not (PSA50 non-responder). The mean percent change from baseline in SUVmax (SUVmax-ave) on PSMA PET between PSA50 responders vs. non-responders will be compared using the Mann-Whitney test.
- Comparison of Change in SUVmax-ave Group on Progression Free Survival (PFS) [ Time Frame: Up to 24 months ]The study cohort will be dichotomized by the median with respect to percent change from baseline in SUVmax-ave on PSMA PET. The time-to-event variables including PSA progression-free defined by PCWG3, radiographic progression-free defined by PCWG3
- Comparison of Change in SUVmax-ave Group on Overall Survival (OS) [ Time Frame: Up to 24 months ]The study cohort will be dichotomized by the median with respect to percent change from baseline in SUVmax-ave on PSMA PET on overall survival defined as time from imaging until death or censored at study completion. OS will be compared between dichotomized subgroups using the log-rank test. Kaplan-Meier product limit method will be used to estimate median survival in each subgroup.
- Comparison between mean percent change in maximum standard uptake value (SUVmax) with objective response group [ Time Frame: Baseline, and up to 16 weeks after initiation of therapy ]Amongst the subset of measurable soft tissue lesions by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, on a per-lesion basis, the mean percent change from baseline in SUVmax on PSMA PET will be compared between responding lesions defined as a complete response or partial response by RECIST 1.1 criteria vs. those without response, using Mann-Whitney test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716725
|Contact: Patricia Li||415-476-5975||GUTrials@ucsf.edu|
|Contact: Maya Aslam||Maya.Aslam@ucsf.edu|
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143|
|Contact: Patricia Li 415-476-5975 GUTrials@ucsf.edu|
|Contact 877-827-3222 firstname.lastname@example.org|
|Principal Investigator: Rahul R. Aggarwal, MD|
|Sub-Investigator: Thomas Hope, MD|
|Principal Investigator:||Rahul R Aggarwal, MD||University of California, San Francisco|