Status:
RECRUITING
New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
BPH (Benign Prostatic Hyperplasia)
Lower Urinary Track Symptoms
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 me...
Detailed Description
Over 90% of adult males develop lower urinary tract symptoms (LUTS) secondary to bladder outlet obstruction by age 80 secondary to benign prostatic hyperplasia (BPH). BPH, the most common proliferativ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- ≥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.
- Exclusion criteria
- 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)
- Claustrophobia that cannot be managed with benzodiazepine
Exclusion
Key Trial Info
Start Date :
December 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2030
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT06944145
Start Date
December 3 2025
End Date
August 31 2030
Last Update
December 5 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215