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

NCT06944145 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2026-03-23

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

Finasteride

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

Sponsors & Collaborators

Principal Investigators

  • Aria Olumi, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-03
Primary Completion
2029-06-01
Completion
2030-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06944145 on ClinicalTrials.gov