This phase II trial studies the use of 68Ga-PSMA-11 positron emission tomography (PET) in diagnosing patients with prostate cancer that continues to grow despite the surgical removal of the testes or medical intervention to block androgen production (castration resistant), and has spread to other places in the body (metastatic). 68Ga- PSMA-11 is a new imaging agent that may help get more detailed pictures of the tumor. This trial aims to see whether using 68Ga-PSMA-11 PET scans may help doctors learn more about where disease is located in the body.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04716725.
PRIMARY OBJECTIVE:
I. To determine whether the percent change from baseline to 16 weeks (+/- 8 weeks) in maximum standard uptake value (SUVmax) averaged across up to 16 lesions per patient (SUVmax-average [ave]) is associated with >= 50% decline from baseline in serum prostate specific antigen (PSA50) response.
SECONDARY OBJECTIVES:
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 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.
OUTLINE:
Patients receive gallium Ga 68 gozetotide intravenously (IV) and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
After completion of study, patients are followed up every 3 months.
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorIvan De Kouchkovsky
