Status:
RECRUITING
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Benign Prostatic Hyperplasia
Prostate Hyperplasia
Eligibility:
MALE
50+ years
Phase:
NA
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...
Detailed Description
Over 90% of adult males develop lower urinary tract symptoms (LUTS) secondary to bladder outlet obstruction by age 80, rendering benign prostatic hyperplasia (BPH) the most common proliferative abnorm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04288427
Start Date
September 25 2020
End Date
November 30 2026
Last Update
October 28 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215