Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06944145

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

Led by Beth Israel Deaconess Medical Center · Updated on 2026-03-23

242

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

Sponsors

B

Beth Israel Deaconess Medical Center

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older at the time of consent
  • Finasteride treatment for BPH recommended by a physician
  • PSA level under 20 ng/ml within the last six months
  • Willing to continue current genitourinary medications (e.g., beta agonists, alpha blockers, anticholinergics)
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • History of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis
  • Previous diagnosis of prostate cancer or precancerous lesions
  • History of pelvic radiation
  • Currently receiving intravesical therapy for bladder cancer
  • Prior treatment with demethylating agents (e.g., azacitidine, decitabine)
  • Current use of warfarin
  • Use of 5-alpha reductase inhibitors in the past year
  • Diagnosis of diabetes mellitus
  • Diagnosis of neurodegenerative diseases
  • Allergy to intravenous iron replacement products
  • Taking cholestyramine medication
  • Contraindications to MRI, including cardiac pacemaker, metal implants near the head, previous metal eye injury, or unmanageable claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

Y

Yulia Mulugeta

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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