Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Jan 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how early hormonal therapies can affect a specific marker, called Prostate-Specific Membrane Antigen (PSMA), in men with recurrent prostate cancer. Researchers want to see if these therapies can increase the amount of PSMA that can be detected using special scans (PET/CT scans). The study will involve about 15 participants who will receive a standard treatment called androgen receptor antagonist monotherapy, which helps block the effects of male hormones that can fuel cancer growth.

To be eligible for this study, participants must be men aged 40 or older who have had previous treatment for prostate cancer and are now experiencing rising PSA levels, indicating a return of the disease. They also need to have had a recent PSMA scan showing signs of recurrent cancer. The entire participation in the study is expected to last around 4 weeks, during which time participants will receive regular scanning and treatment. It’s important to note that some individuals may not qualify, especially if they have advanced disease or other health issues that could complicate the study.

Gender

MALE

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 situation requiring medical/surgical castration and/or docetaxel during the time of the study.
• • Not suitable for AR antagonist therapy (e.g. inability to swallow pills, poor adherence, advanced liver disease, prohibitive co-payment without available patient assistance funding, contraindicated drug-drug interaction).
• • Older-generation AR antagonists (e.g. bicalutamide) are not allowed on study.