5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Finasteride

Criteria

Inclusion Criteria:

• Male (physiological);

• Age ≥ 50;

• Eligible for treatment with 5ARI therapy;

• Presence of lower urinary tract symptoms secondary to BPH;

• Lower urinary tract symptoms with a AUA urinary symptom score >8;

• Prostate size >40cc by digital rectal examination;

• Absence of prostate nodule, tenderness or firmness;

• Mildly elevated PSA's >4 ng/ml and ≤ 10 ng/ml;

• Undergoing clinically indicated prostate biopsy for elevated 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 diabetes mellitus, 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.