Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Understanding the Interaction Between Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Sponsor: Beth Israel Deaconess Medical Center + Dana-Farber Cancer Institute
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Proportion of Participants with New Lesions (Flare)
Time frame: week 1
Proportion of Participants with New Lesions (Flare)
Time frame: week 4
Secondary Endpoints
Changes in tumor size
Changes in tumor size
Changes in tumor SUV
Eligibility Criteria
Inclusion Criteria: * Patients age 40 or higher with prostate cancer that has been previously treated with primary definitive local therapies (prostatectomy with or without salvage radiation, or primary prostate radiation) and subsequently experiencing rising PSA meeting criteria for biochemical failure (PSA \>0.2 ng/dL x2 following prostatectomy, or PSA \> 2 + nadir value following primary radiation). * PSMA PET/CT (Ga68, piflutolastat F-18, or other FDA-approved tracer) during time of biochemical recurrence, and within 6 weeks of registration, showing at least one lesion suspicious for recurrent prostate cancer based on size and/or SUV. * Testosterone \>100 ng/dL within 6 months prior to enrollment with no intervening hormonal therapies. * Assigned by treating physician to receive standard-of-care AR antagonist monotherapy, using FDA-approved apalutamide, darolutamide, or enzalutamide. Exclusion Criteria: * High disease burden, significant symptoms of disease, or other clinical si…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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