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New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia

RecruitingPhase 2

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)

Who can join

Ages 18 and older · Men

Full 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

About the study

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.

What is being tested

Sponsor: Beth Israel Deaconess Medical Center · Participants: 242 · Started: Dec 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06944145

Locations in the U.S.

MassachusettsBeth Israel Deaconess Medical Center, Boston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.