NCT05683964

Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

Understanding the Interaction Between Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This research study is a pilot study, and it is the first time investigators are directly examining the effect of standard androgen receptor antagonists on Prostate-Specific Membrane Antigen (PSMA) expression for participants with recurrent, asymptomatic, metastatic hormone-sensitive prostate cancer (mHSPC). This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy. The research study procedures include screening for eligibility, study imaging and evaluations, blood collections, and follow up visits. The names of the treatment interventions involved in this study are: * Androgen receptor antagonist monotherapy. * PSMA PET/CT scan The U.S. Food and Drug Administration (FDA) has approved apalutamide, darolutamide, and enzalutamide for the treatment of prostate cancer. 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. Funding for this research study is provided by a philanthropic gift.

Conditions

• Prostate Adenocarcinoma
• Prostate Cancer
• Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Interventions

Type	Name	Description
DRUG	Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]	per standard care
DIAGNOSTIC_TEST	Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan	Per standard care

Timeline

• Start date: 2023-01-19
• Primary completion: 2025-09-18
• Completion: 2026-09-01
• First posted: 2023-01-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study