Combination finasteride plus raloxifene therapy with epigenetic biomarker testing for benign prostate enlargement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional effort at Beth Israel Deaconess will enroll adult men recommended for finasteride to test a combination of finasteride and the estrogen modulator raloxifene. The study uses epigenetic biomarker testing, including SRD5A2 promoter methylation and noninvasive assays, to identify men who lack SRD5A2 expression and may be resistant to 5α‑reductase inhibitors. Participants will receive study medications and be followed for symptomatic and biological responses related to lower urinary tract symptoms and prostate size. Outcomes and biomarker changes will be compared to determine whether the combination therapy improves response in men with SRD5A2 suppression.

Why it matters

Who can join: the full rules

Inclusion criteria

1. ≥18 yrs old on the day of study consent;
2. Finasteride has been recommended for treatment of BPH by a physician;
3. PSA \<20ng/ml within the last six months;
4. Willingness to maintain any current genitourinary medications (e.g., beta agonists, alpha blockers, anticholinergics);
5. Patient is able and willing to provide written informed consent.

Exclusion criteria

1. Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis;
2. Previous diagnosis with any prostatic malignancy or precancerous lesions (atypical glandular foci);
3. History of pelvic radiation;
4. Actively receiving intravesical therapy for bladder cancer;
5. Received treatment with any demethylating medications (azacitidine, decitabine, zebularine, guadecitabine, hydralazine);
6. Current use of warfarin;
7. Prior treatment with 5ARI medications (e.g., Finasteride or Dutasteride) in the last year;
8. Diagnosed with diabetes mellitus;
9. Diagnosed with any neurodegenerative diseases;
10. History of allergic reaction to any intravenous (IV) iron replacement products;
11. Currently taking cholestyramine medication;
12. 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)
    * Claustrophobia that cannot be managed with benzodiazepine

Where it's running

• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Aria Olumi, MD — Beth Israel Deaconess Medical Center
• Study coordinator: Yulia Mulugeta
• Email: ymuluget@bidmc.harvard.edu
• Phone: 617-632-8890

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.