New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorBeth Israel Deaconess Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
≥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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- raloxifene
- Finasteride
Treatment groups
242 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beth Israel Deaconess Medical Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov