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

Inclusion Criteria8

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 Criteria7

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.

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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.