Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
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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