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

NCT06944145 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025P000440R01DK142211
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

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

BPH (Benign Prostatic Hyperplasia); Lower Urinary Track Symptoms

Keywords

BPH; SRD5A2; Finasteride; LUTS

Outcome Measures

Primary Outcomes (1)

• Clinical response to at 12 months after study enrollment

  The primary endpoint is the clinical response (yes-no) to therapy at 12 months after study enrollment between the combination and monotherapy treatment groups. Clinical response will be defined as ≥3-point decrease in International Prostate Symptom Score between baseline and the 12-month timepoint, adjusting for baseline measure of International Prostate Symptom Score. The minimal International Prostate Symptom Score is 0, denoting no symptoms, and the maximum score is 35, denoting severe symptoms.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (5)

• Heterogeneity of clinical response to at 12 months after study enrollment by methylation score

  From enrollment to the end of treatment at 12 months

• Comparison of mean International Prostate Symptom Score between study arms

  From enrollment to the end of treatment at 12 months

• Comparison of mean International Index of Erectile Function Questionnaire scores between study arms

  From enrollment to the end of treatment at 12 months

• Correlation between methylation and MRI scores

  From enrollment to the end of treatment at 12 months

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Finasteride + Inactive Placebo Monotherapy

ACTIVE COMPARATOR

Participants may be randomized into the Finasteride + Inactive Placebo Monotherapy arm.

Drug: Finasteride

Finasteride + Raloxifene Combination Therapy

EXPERIMENTAL

Participants may be randomized into the Finasteride + Raloxifene Combination Therapy arm.

Drug: raloxifene; Drug: Finasteride

Interventions

Finasteride DRUG

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

Finasteride + Inactive Placebo Monotherapy; Finasteride + Raloxifene Combination Therapy

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 + Raloxifene Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 yrs old on the day of study consent;
• Finasteride has been recommended for treatment of BPH by a physician;
• PSA \<20ng/ml within the last six months;
• Willingness to maintain any current genitourinary medications (e.g., beta agonists, alpha blockers, anticholinergics);
• Patient is able and willing to provide written informed consent.

You may not qualify if:

• Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis;
• Previous diagnosis with any prostatic malignancy or precancerous lesions (atypical glandular foci);
• History of pelvic radiation;
• Actively receiving intravesical therapy for bladder cancer;
• Received treatment with any demethylating medications (azacitidine, decitabine, zebularine, guadecitabine, hydralazine);
• Current use of warfarin;
• Prior treatment with 5ARI medications (e.g., Finasteride or Dutasteride) in the last year;
• Diagnosed with diabetes mellitus;
• Diagnosed with any neurodegenerative diseases;
• History of allergic reaction to any intravenous (IV) iron replacement products;
• Currently taking cholestyramine medication;
• Contraindications to MRI examination, which may include:
• Cardiac pacemaker
• Intracranial clips, metal implants, or external clips within 10mm of the head
• Previous metal injury in the eye or occupation risk to ferrous metal in the eye (e.g. metalworker)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Raloxifene Hydrochloride; Finasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Aria Olumi, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yulia Mulugeta

CONTACT

617-632-8890; ymuluget@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Urology, BIDMC

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 25, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): August 31, 2030
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

US (1)