Combination finasteride plus raloxifene therapy with epigenetic biomarker testing for benign prostate enlargement
A Phase 2b Randomized, Single-Center, Double Blind, Placebo Controlled, 2-Arm Study to Investigate Orally Administered Combination Therapies (5-alpha Reductase Inhibitor + Raloxifene) Compared With Monotherapy (5-alpha Reductase Inhibitor + Placebo) in Adult Patients With Benign Prostatic Hyperplasia (BPH)
PHASE2 · Beth Israel Deaconess Medical Center · NCT06944145
This project will test whether adding raloxifene to finasteride and using epigenetic biomarker tests helps men with benign prostate enlargement who are candidates for finasteride.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 242 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Beth Israel Deaconess Medical Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06944145 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult men for whom finasteride has been recommended, with PSA below 20 ng/mL, willing to provide informed consent and to maintain any current genitourinary medications.
Not a fit: Patients with a history of venous thromboembolism, prior prostate cancer or precancerous lesions, pelvic radiation, current warfarin use, recent 5α‑reductase inhibitor treatment, or current use of demethylating medications are excluded and would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could help identify men unlikely to respond to finasteride and offer an alternative combination therapy to reduce prostate growth and urinary symptoms.
How similar studies have performed: Preclinical and translational work supports SRD5A2 epigenetic regulation and finasteride resistance, but the specific combination of 5‑ARI plus raloxifene with noninvasive biomarker guidance is largely novel in clinical testing.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: BPH, Lower Urinary Track Symptoms, SRD5A2, Finasteride, LUTS