Home › Enlarged Prostate (BPH) › NCT06944145
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)
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 benzodiazepineAbout 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
- raloxifene (drug)
- Finasteride (drug)
Sponsor: Beth Israel Deaconess Medical Center · Participants: 242 · Started: Dec 3, 2025
Contact the study team
- Yulia Mulugeta · Phone: 617-632-8890
Official record on ClinicalTrials.gov — NCT06944145
Locations in the U.S.
| Massachusetts | Beth 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.