Clinical Trial · NCT05683964

Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

Overview

The goal of this research study is to determine whether hormonal therapies used early in the course of prostate cancer could increase the amount of Prostate-Specific Membrane Antigen (PSMA) as detected by PET/CT scans for participants with recurrent prostate cancer. This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy. The names of the treatment interventions involved in this study are: * Androgen receptor antagonist monotherapy. * PSMA PET/CT scan It is expected that about 15 people will take part in this research study. Participation in this research study is expected to last about 4 weeks.

Sponsor

Beth Israel Deaconess Medical Center

Phase

Early Phase 1

Contacts

David Einstein, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05683964

Eligibility

Inclusion

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.
Assigned by treating physician to receive standard-of-care AR antagonist monotherapy, using FDA-approved apalutamide, darolutamide, or enzalutamide.
Testosterone \>100 ng/dL within 6 months prior to enrollment with no intervening hormonal therapies.

Exclusion

High disease burden, significant symptoms of disease, or other clinical situation requiring medical/surgical castration and/or docetaxel during the time of the study.
Older-generation AR antagonists (e.g. bicalutamide) are not allowed on 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).