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5-Alpha Reductase Inhibitor

Finasteride for Enlarged Prostate

N/A
Recruiting
Led By Aria F. Olumi, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male (physiological)
Eligible for treatment with 5ARI therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessment of finasteride responsiveness through changes in urinary symptoms will be completed at 6 month intervals during clinic visits, and treatment efficacy will be determined after the first 12 months.
Awards & highlights

Study Summary

This trial is studying why some patients with an enlarged prostate don't respond to the drug finasteride, and if MRI can help predict which patients will respond.

Who is the study for?
Men over 50 with an enlarged prostate (BPH) and urinary symptoms who haven't had certain treatments like Finasteride recently. They should have a mildly elevated PSA level, no prostate nodules or tenderness, and be able to undergo an MRI. Those with neurological conditions, past pelvic radiation, current UTI, or previous cancerous prostate lesions can't join.Check my eligibility
What is being tested?
The trial is studying why some men with BPH don't respond to Finasteride. It's testing if MRI scans can identify inflammation in the prostate that might predict non-response to the drug so alternative treatments can be offered sooner.See study design
What are the potential side effects?
Finasteride may cause sexual side effects such as decreased libido, erectile dysfunction, ejaculation disorders; also possible are swelling in hands or feet, dizziness, weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a biological male.
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I am eligible for 5-alpha-reductase inhibitor therapy.
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My prostate is larger than normal as determined by a physical exam.
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I am 50 years old or older.
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My prostate does not have any lumps, pain, or hardness.
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I have urinary problems due to an enlarged prostate.
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I am having a prostate biopsy due to high PSA levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessment of finasteride responsiveness through changes in urinary symptoms will be completed at 6 month intervals during clinic visits, and treatment efficacy will be determined after the first 12 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessment of finasteride responsiveness through changes in urinary symptoms will be completed at 6 month intervals during clinic visits, and treatment efficacy will be determined after the first 12 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Finasteride treatment effect on lower urinary tract symptom improvement by urinary symptom score

Side effects data

From 2017 Phase 4 trial • 383 Patients • NCT01296672
1%
Rash
1%
Decreased libido
100%
80%
60%
40%
20%
0%
Study treatment Arm
Finasteride
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Finasteride TreatmentExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Finasteride
1995
Completed Phase 4
~5940

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
840 Previous Clinical Trials
13,011,599 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,315,296 Total Patients Enrolled
Aria F. Olumi, MD4.511 ReviewsPrincipal Investigator - Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
5Patient Review
Dr. Olumi was very professional, sincere, and responsible. I had a very good experience, I was seen in timely manner and followed through after surgery. I had some minor complications and he personally came to the hospital to take care of me. He is an expert in his specialties and has excellent communication with his patients. He was very informative and made sure I understood my condition, the procedure, and post-surgical care. I would highly recommend Dr. Olumi to anyone who is looking for an excellent Urologist.

Media Library

Finasteride (5-Alpha Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04288427 — N/A
Enlarged Prostate Research Study Groups: Finasteride Treatment
Enlarged Prostate Clinical Trial 2023: Finasteride Highlights & Side Effects. Trial Name: NCT04288427 — N/A
Finasteride (5-Alpha Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04288427 — N/A
~25 spots leftby Jun 2025