Investigating hormonal therapies and PSMA levels in prostate cancer
Understanding the Interaction Between Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
This study is testing if early hormonal treatments can improve the detection of a specific marker in men with recurrent, asymptomatic prostate cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05683964 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the impact of early hormonal therapies on Prostate-Specific Membrane Antigen (PSMA) expression in patients with recurrent, asymptomatic metastatic hormone-sensitive prostate cancer (mHSPC). Participants will receive standard-of-care androgen receptor antagonist monotherapy and undergo PSMA PET/CT scans to measure PSMA levels. The study will involve screening for eligibility, imaging evaluations, blood collections, and follow-up visits over a period of approximately four weeks. The goal is to determine if these therapies can enhance PSMA detection in patients.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 or older with a history of prostate cancer who have experienced biochemical recurrence after primary treatment.
Not a fit: Patients with high disease burden or significant symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the detection and management of recurrent prostate cancer through enhanced PSMA imaging.
How similar studies have performed: While this approach is novel in directly examining the effects of androgen receptor antagonists on PSMA expression, similar studies have shown promise in enhancing imaging techniques for prostate cancer.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: David Einstein, MD — Beth Israel Deaconess Medical Center
- Study coordinator: David Einstein, MD
- Email: deinstei@bidmc.harvard.edu
- Phone: (617) 667-1957
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.