Enlarged Prostate (BPH) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 50
Healthy Volunteers: f
View:

• 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).

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Yulia Mulugeta, BS
ymuluget@bidmc.harvard.edu
617-632-8890
Time Frame
Start Date: 2020-09-25
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 120
Treatments
Experimental: Finasteride Treatment
Patients who are eligible will be given 5ARI therapy, Finasteride, for medical management of Benign Prostatic Hyperplasia (BPH) symptoms. Only patients with lower urinary tract symptoms (LUTS) as assessed by American Urologic Association (AUA) urinary symptom score \> than 8, (suggestive of moderate LUTS) prostate size \> 40cc, no prostate nodule/tenderness/firmness and increased PSA between 4-10ng/ml requiring prostate biopsy will be enrolled. Then, they will have prostate MRIs/needle biopsies and blood/urine collection followed by treatment with Finasteride (standard of care). They will be followed in urology clinic for assessment of LUTS every 6 months and Finasteride responsiveness at the 12-month time point. Prostate biopsy samples will be evaluated for SRD5A2 gene expression/methylation, hormonal androgen/estrogen levels (which will be repeated in blood samples). Prostate MRIs will assess size/inflammatory changes at the start and 3-year time points.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov

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