NCT06944145 · Beth Israel Deaconess Medical Center
New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations