RecruitingNot ApplicableNCT04288427

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

Sponsor

Beth Israel Deaconess Medical Center

Enrollment

120 participants

Start Date

Sep 25, 2020

Study Type

INTERVENTIONAL

Conditions

Prostate Hyperplasia Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Prostate Disease Urinary Tract Disease Prostate Hypertrophy Prostate Pain Urinary Obstruction

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

Sex: MALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Finasteride for people with benign prostatic hyperplasia, lower urinary tract symptoms, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFinasteride

Patients who are candidates to receive 5ARI therapy, Finasteride, for clinical medical management of lower urinary tract symptoms will begin treatment once deemed eligible. They will be assess every 6 months for changes in urinary symptom scores and their responsiveness to the Finasteride treatment will be assessed at the 12-month time point. MRIs of prostate taken at the start of study and at the 3 year time point will assess prostate size and changes in size as well as degree of inflammatory changes. Gene expression of SRD5A2 as well as methylation pattern will be tested on prostate tissue samples, where hormonal androgen/estrogen levels will also be assessed as they are in blood samples.