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
This trial does not accept healthy volunteersQualifiers
≥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
Design model
Parallel
Treatments tested in this trial
raloxifene
DrugParticipants in the Finasteride + Raloxifene Combination Therapy Arm will receive both Finasteride and Raloxifene as their intervention. Participants randomized to the Finasteride + Raloxifene Combination Therapy arm will self-administer finasteride at 5 mg orally/day and raloxifene at 60 mg orally/day.
Finasteride
DrugParticipants randomized to the Finasteride + Inactive Placebo Monotherapy arm will self-administer finasteride at 5 mg orally/day and placebo capsule daily.
Treatment groups
242 Participants
are divided into 2 treatment groupsGroup A: Finasteride + Inactive Placebo MonotherapyActive comparator 1 intervention
Group B: Finasteride + Raloxifene Combination TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Clinical response to at 12 months after study enrollment
The primary endpoint is the clinical response (yes-no) to therapy at 12 months after study enrollment between the combination and monotherapy treatment groups. Clinical response will be defined as ≥3-point decrease in International Prostate Symptom Score between baseline and the 12-month timepoint, adjusting for baseline measure of International Prostate Symptom Score. The minimal International Prostate Symptom Score is 0, denoting no symptoms, and the maximum score is 35, denoting severe symptoms.
Time frame
From enrollment to the end of treatment at 12 monthsSecondary outcomes
1
Heterogeneity of clinical response to at 12 months after study enrollment by methylation score
Assessing the clinical response (yes-no) to therapy at 12 months after study enrollment between the combination and monotherapy treatment groups. Clinical response will be defined as ≥3-point decrease in International Prostate Symptom Score between baseline and the 12-month timepoint, adjusting for baseline measure of International Prostate Symptom Score. We will examine whether methylation score modifies the effect of treatment group on the primary endpoint by testing statistical interaction between treatment group and methylation score. The minimal International Prostate Symptom Score is 0, denoting no symptoms, and the maximum score is 35, denoting severe symptoms.
Time frame
From enrollment to the end of treatment at 12 months2
Comparison of mean International Prostate Symptom Score between study arms
Mean 12-month International Prostate Symptom Score will be compared between study arms, adjusting for baseline International Prostate Symptom Score. The minimal International Prostate Symptom Score is 0, denoting no symptoms, and the maximum score is 35, denoting severe symptoms.
Time frame
From enrollment to the end of treatment at 12 months3
Comparison of mean International Index of Erectile Function Questionnaire scores between study arms
Mean 12-month International Index of Erectile Function (IIEF) Questionnaire scores will be compared between study arms, adjusting for baseline International Index of Erectile Function score. A score of 0 to 5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The overall minimum score is 0, which indicates poor erectile function and the maximum score is 75 indicating good erectile function.
Time frame
From enrollment to the end of treatment at 12 months4
Correlation between methylation and MRI scores
Time frame
From enrollment to the end of treatment at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov