NCT06944145 New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
| NCT ID | NCT06944145 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | BPH (Benign Prostatic Hyperplasia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 242 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2029-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 242 participants in total. It began in 2025-12-03 with a primary completion date of 2029-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
SRD5A2 is a critical enzyme for prostatic development and growth, and the SRD5A2 inhibitor, finasteride, is used to treat benign prostatic hyperplasia (BPH). SRD5A2 is absent in 30% of normal adult men, which explains the resistance of a subset of patients to this commonly prescribed drug. This project proposes new combination therapies (5-ARI+raloxifene) and evaluates novel non-invasive biomarkers, based on alternative pathways that lead to prostatic enlargement.
Eligibility Criteria
Inclusion criteria 1. ≥18 yrs old on the day of study consent; 2. Finasteride has been recommended for treatment of BPH by a physician; 3. PSA \<20ng/ml within the last six months; 4. Willingness to maintain any current genitourinary medications (e.g., beta agonists, alpha blockers, anticholinergics); 5. Patient is able and willing to provide written informed consent. Exclusion criteria 1. Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis; 2. Previous diagnosis with any prostatic malignancy or precancerous lesions (atypical glandular foci); 3. History of pelvic radiation; 4. Actively receiving intravesical therapy for bladder cancer; 5. Received treatment with any demethylating medications (azacitidine, decitabine, zebularine, guadecitabine, hydralazine); 6. Current use of warfarin; 7. Prior treatment with 5ARI medications (e.g., Finasteride or Dutasteride) in the last year; 8. Diagnosed with diabetes mellitus; 9. Diagnosed with any neurodegenerative diseases; 10. History of allergic reaction to any intravenous (IV) iron replacement products; 11. Currently taking cholestyramine medication; 12. Contraindications to MRI examination, which may include: * Cardiac pacemaker * Intracranial clips, metal implants, or external clips within 10mm of the head * Previous metal injury in the eye or occupation risk to ferrous metal in the eye (e.g. metalworker) * Claustrophobia that cannot be managed with benzodiazepine
Contact & Investigator
Aria Olumi, MD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT06944145 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying BPH (Benign Prostatic Hyperplasia). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06944145 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06944145 currently recruiting?
Yes, NCT06944145 is actively recruiting participants. Contact the research team at ymuluget@bidmc.harvard.edu for enrollment information.
Where is the NCT06944145 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06944145 clinical trial?
NCT06944145 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is Aria Olumi, MD at Beth Israel Deaconess Medical Center. The trial plans to enroll 242 participants.