5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
Beth Israel Deaconess Medical Center
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.
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 abnormality in humans. LUTS secondary to BPH negatively impact the quality of life of 210 million men globally, accounting for significant life years lost, in addition to costing the US healthcare system over $4 billion per year. Medical therapy for the management of BPH, which includes α-adrenergic blockers (e.g., doxazosin, terazosin, tamsulosin or alfuzosin) and 5α reductase inhibitors (5ARI, i.e., f…
Eligibility
- Age range
- 50+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * Diagnosis of any prostatic malignancy or precancerous lesions (atypical glandular foci and prostatic intraepithelial neoplasia); * Treatment with 5ARI (Finast…
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.
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts