NCT04288427 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
| NCT ID | NCT04288427 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-09-25 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2020-09-25 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is being conducted to learn why some patients with Benign Prostatic Hyperplasia (BPH) do not respond to a commonly used treatment drug, Finasteride. The hope is to find ways to predict which patients will not respond to Finasteride so that, in the future, these patients can be identified prior to offering this treatment and they can be offered alternative treatment strategies in its place. The aim is to see if noninvasive techniques such as MRI can detect inflammation of the prostate to assist with early detection of those who will and who will not respond to Finasteride.
Eligibility Criteria
Inclusion Criteria: * Male (physiological); * Age ≥ 50; * Eligible for treatment with 5ARI therapy; * Presence of lower urinary tract symptoms secondary to BPH; * Prostate size \>40cc by digital rectal examination; * Absence of prostate nodule, tenderness or firmness; * Mildly elevated PSA's \>1.5 ng/ml and ≤ 40 ng/ml; * Undergoing clinically indicated prostate biopsy for elevated prostate-specific antigen (PSA). Exclusion Criteria: * Diagnosis of any prostatic malignancy or precancerous lesions (atypical glandular foci and prostatic intraepithelial neoplasia); * Treatment with 5ARI (Finasteride or Dutasteride) within six months of study enrollment; * Current urinary tract infection; * Previous pelvic radiation; * Previous treatment with demethylating drugs; * Diagnosis of multiple sclerosis, Alzheimer's, Parkinson's, neurological deficits in the judgment of the investigator; * Unable or unwilling to undergo MRI due to implants, claustrophobia, etc.
Contact & Investigator
Aria F. Olumi, MD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT04288427 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04288427 currently recruiting?
Yes, NCT04288427 is actively recruiting participants. Contact the research team at ymuluget@bidmc.harvard.edu for enrollment information.
Where is the NCT04288427 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04288427 clinical trial?
NCT04288427 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is Aria F. Olumi, MD at Beth Israel Deaconess Medical Center. The trial plans to enroll 120 participants.