5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
Benign Prostatic Hyperplasia, Prostate Hyperplasia, Prostate Disease
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Finasteride, 5 Alpha Reductase
Eligibility Criteria
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 >2.5 ng/ml and ≤ 20 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 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.
Sites / Locations
- Beth Israel Deaconess Medical CenterRecruiting
Arms of the Study
Arm 1
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.