This trial studies the effect of androgen receptor signaling inhibitors on 68Ga-PSMA-11 PET/CT imaging in patients with castration-resistant prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help in learning how well androgen receptor signaling inhibitors work in killing castration-resistant prostate cancer cells and allow doctors to plan better treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04279561.
PRIMARY OBJECTIVE:
I. To evaluate short- and long-term prostate specific membrane antigen (PSMA) imaging changes in response to androgen receptor signaling inhibitors (ARSI).
SECONDARY OBJECTIVES:
I. To correlate PSMA imaging changes with prostate specific antigen (PSA) kinetics.
II. To correlate PSMA imaging changes with progression free survival.
III. To evaluate the changes in PSMA PET staging (miTNM Prostate Cancer Molecular Imaging Standardized Evaluation [PROMISE] criteria) under ARSI.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) intravenously (IV). After 50-100 minutes, patients undergo positron emission tomography (PET)/computed tomography (CT) over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 and 2 weeks after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorJeremie Calais