Recruiting
Phase 2

5-ARI & Raloxifene

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06944145

Conditions

BPH (Benign Prostatic Hyperplasia)

Lower Urinary Track Symptoms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

raloxifene

Finasteride

Study Details

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.

Conditions

BPH (Benign Prostatic Hyperplasia)

Lower Urinary Track Symptoms

Study ID

NCT06944145

Start date

Dec 3, 2025

Status verified date

Mar, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

242 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Finasteride + Inactive Placebo Monotherapy

Participants may be randomized into the Finasteride + Inactive Placebo Monotherapy arm.

experimental: Finasteride + Raloxifene Combination Therapy

Participants may be randomized into the Finasteride + Raloxifene Combination Therapy arm.

Interventions

raloxifene

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.

Finasteride

Participants randomized to the Finasteride + Inactive Placebo Monotherapy arm will self-administer finasteride at 5 mg orally/day and placebo capsule daily.

Primary outcome measure

  • Clinical response to at 12 months after study enrollment [ Time Frame: From enrollment to the end of treatment at 12 months ]

Central Contacts and Locations

Central contacts

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • BPH
  • SRD5A2
  • Finasteride
  • LUTS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-03-23.