Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Beth Israel Deaconess Medical Center
- Study ID
- NCT05683964
- Phase
- EARLY_PHASE1
- Status
- Active Not Recruiting
Conditions
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Prostate Adenocarcinoma
- Prostate Cancer
Eligibility Criteria
- Sex
- MALE
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi] — DRUGper standard care
- Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan — DIAGNOSTIC_TESTPer standard care
Study Details
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.
Key Dates
- Start date
- Jan 19, 2023
- Status verified
- Feb 2026
- Primary completion
- Sep 18, 2025
- Completion
- Sep 1, 2026
Study Design
- Enrollment
- 9 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Androgen Receptor Antagonist Monotherapy* Participants will receive pre-determined doses of apalutamide, darolutamide, or enzalutamide per standard care. * Participants will undergo Prostate-Specific Membrane Antigen (PSMA) PET/CT scans at weeks 1 and 4.
Primary Outcome Measure
Proportion of Participants with New Lesions (Flare) [ Time Frame: week 1 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | - |
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