Actively Recruiting
A Phase 2b Study Comparing Finasteride Plus Raloxifene Combination Therapy With Finasteride Plus Placebo in Adult Men With Benign Prostatic Hyperplasia
Led by Beth Israel Deaconess Medical Center · Updated on 2026-03-23
242
Participants Needed
1
Research Sites
65 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
This research investigates new treatment strategies and biomarkers for benign prostatic hyperplasia (BPH), a common condition causing urinary symptoms in older men. It focuses on why some patients do not respond to the usual drug finasteride, which targets the SRD5A2 enzyme important for prostate growth. The study explores how epigenetic changes and inflammation affect this enzyme and aims to find better therapies by combining finasteride with raloxifene, plus new ways to detect treatment resistance using non-invasive biomarkers. Participants will be randomly assigned to one of two groups: one receiving finasteride plus a placebo, and the other receiving finasteride combined with raloxifene. Both medications are taken orally once daily. The trial is double-blinded and lasts 12 months, during which researchers will monitor treatment effects and evaluate if the methylation status of the SRD5A2 gene can predict response. The study will also assess prostate inflammation using imaging techniques. During the study, participants will be regularly assessed for clinical response, prostate symptoms, and erectile function using questionnaires. Blood tests and MRI scans will be used to measure biomarkers and inflammation. The main outcome is the clinical response after one year of treatment, along with safety monitoring for any side effects. This trial is conducted with adult men recommended finasteride for BPH and involves close follow-up for a full year.
CONDITIONS
Brief Title
New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older on the day of study consent
- Finasteride has been recommended for treatment of benign prostatic hyperplasia by a physician
- PSA less than 20 ng/ml within the last six months
- Willingness to maintain any current genitourinary medications such as beta agonists, alpha blockers, or 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 prostatic cancer or precancerous lesions
- History of pelvic radiation
- Currently receiving intravesical therapy for bladder cancer
- Previous treatment with demethylating medications such as azacitidine or decitabine
- Current use of warfarin
- Prior treatment with 5-alpha reductase inhibitors in the last year
- Diagnosis of diabetes mellitus
- Diagnosis of any neurodegenerative diseases
- History of allergic reaction to intravenous iron replacement products
- Currently taking cholestyramine medication
- Contraindications to MRI, including cardiac pacemaker, metal implants near the head, metal injury in the eye, or unmanaged claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either finasteride plus raloxifene combination therapy or finasteride plus placebo daily to manage benign prostatic hyperplasia.
Regular visits during the 12-month treatment period
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
Y
Yulia Mulugeta
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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