New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
A Phase 2b Randomized, Single-Center, Double Blind, Placebo Controlled, 2-Arm Study to Investigate Orally Administered Combination Therapies (5-alpha Reductase Inhibitor + Raloxifene) Compared With Monotherapy (5-alpha Reductase Inhibitor + Placebo) in Adult Patients With Benign Prostatic Hyperplasia (BPH)
Beth Israel Deaconess Medical Center
242 participants
Dec 3, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- ≥18 yrs old on the day of study consent;
- Finasteride has been recommended for treatment of BPH by a physician;
- PSA \<20ng/ml within the last six months;
- Willingness to maintain any current genitourinary medications (e.g., beta agonists, alpha blockers, anticholinergics);
- Patient is able and willing to provide written informed consent.
Exclusion Criteria16
- Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis;
- Previous diagnosis with any prostatic malignancy or precancerous lesions (atypical glandular foci);
- History of pelvic radiation;
- Actively receiving intravesical therapy for bladder cancer;
- Received treatment with any demethylating medications (azacitidine, decitabine, zebularine, guadecitabine, hydralazine);
- Current use of warfarin;
- Prior treatment with 5ARI medications (e.g., Finasteride or Dutasteride) in the last year;
- Diagnosed with diabetes mellitus;
- Diagnosed with any neurodegenerative diseases;
- History of allergic reaction to any intravenous (IV) iron replacement products;
- Currently taking cholestyramine medication;
- 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
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Interventions
Participants in the Finasteride + Raloxifene Combination Therapy Arm will receive both Finasteride and Raloxifene as their intervention. Participants randomized to the Finasteride + Raloxifene Combination Therapy arm will self-administer finasteride at 5 mg orally/day and raloxifene at 60 mg orally/day.
Participants randomized to the Finasteride + Inactive Placebo Monotherapy arm will self-administer finasteride at 5 mg orally/day and placebo capsule daily.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06944145