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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 1 of 5 entriesv5
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 2025 to Dec 3, 2025 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Nov 2025 to Dec 3, 2025
    • Site details revised
  3. Start date: Oct 1, 2025 to Nov 2025 Primary endpoints: 4 to 1 · Study sites: 0 to 1 · Eligibility criteria expanded, about 116 words · 3 morev3 Show 6 more changesShow less
    • Primary endpoints: 4 to 1
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 116 words
    • Secondary endpoints: 2 to 5
    • Collaborators expanded, about 10 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Jun 1, 2025 to Oct 1, 2025 Completion date: Aug 31, 2029 to Aug 31, 2030v2 Show 1 more changeShow less
    • Completion date: Aug 31, 2029 to Aug 31, 2030
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06944145
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions BPH (Benign Prostatic Hyperplasia), Lower Urinary Track Symptoms
Enrollment 242 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov