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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT06944145
Phase
PHASE2
Status
Recruiting
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Conditions

  • BPH (Benign Prostatic Hyperplasia)
  • Lower Urinary Track Symptoms

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 3, 2025
Status verified
Mar 2026
Primary completion
Jun 1, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
242 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Yulia Mulugeta
[email protected]
617-632-8890

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Beth Israel Deaconess Medical Center· Boston, MA

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