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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

Must not have

Current urinary tract infection

Diagnosis of any prostatic malignancy or precancerous lesions (atypical glandular foci and prostatic intraepithelial neoplasia)

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a urinary tract infection right now.

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I have been diagnosed with a type of prostate cancer or precancerous prostate condition.

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I have had radiation therapy to my pelvic area before.

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I have been treated with drugs that affect DNA methylation.

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I have taken Finasteride or Dutasteride in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Finasteride treatment effect on lower urinary tract symptom improvement by urinary symptom score

Side effects data

From 2017 Phase 4 trial • 383 Patients • NCT01296672

Decreased libido

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Finasteride

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6060

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

855 Previous Clinical Trials

12,930,674 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,449 Previous Clinical Trials

4,332,347 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.