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

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Feb 26, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at why some men with Benign Prostatic Hyperplasia (BPH), a condition that causes an enlarged prostate and can lead to uncomfortable urinary symptoms, do not respond to a common medication called Finasteride. The researchers aim to find a way to predict which patients might not benefit from this drug, so they can offer other treatment options instead. They will use non-invasive methods, like MRI scans, to check for inflammation in the prostate, which may help identify those who will respond well to Finasteride and those who won't.

To participate in this study, men aged 50 and older who are experiencing urinary issues related to BPH might be eligible. They should have a prostate size larger than 40cc and a mildly elevated PSA level (a blood marker related to prostate health). However, individuals with any form of prostate cancer, recent treatment with similar medications, or certain health conditions will not be able to join. Participants will undergo an MRI and might have to undergo a prostate biopsy as part of the study. This trial is currently recruiting, and it could help improve treatment options for men experiencing BPH in the future.

Gender

MALE

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 \>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 (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.