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.
Eligible Conditions
- Enlarged Prostate
- Benign Prostatic Hyperplasia
- Urinary Obstruction
- Prostatitis
- Urinary Tract Infection (UTI)
- Lower Urinary Tract Symptoms (LUTS)
- Prostate Disease
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 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.
Month 12
Finasteride treatment effect on lower urinary tract symptom improvement by urinary symptom score
Trial Safety
Phase-Based Safety
Side Effects for
Finasteride
1%Decreased libido
1%Rash
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
1 Treatment Group
Finasteride Treatment
1 of 1
Experimental Treatment
120 Total Participants · 1 Treatment Group
Primary Treatment: Finasteride · No Placebo Group · N/A
Finasteride Treatment
Drug
Experimental Group · 1 Intervention: Finasteride · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Finasteride
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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.
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,213 Previous Clinical Trials
4,193,433 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
791 Previous Clinical Trials
849,414 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.
Eligibility Criteria
Age 18+ · Male Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have difficulty urinating due to an enlarged prostate gland.
You are a biological male.
You are able to receive 5ARI therapy as a treatment option.
Who else is applying?
What state do they live in?
| California | 25.0% |
| North Carolina | 25.0% |
| Virginia | 25.0% |
| Other | 25.0% |
What site did they apply to?
| Beth Israel Deaconess Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
References
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Frequently Asked Questions
What is the population size for this experimental research?
"Affirmative. According to the information recorded on clinicaltrials.gov, this research trial is currently looking for participants; it was initially posted on September 25th 2020 and last updated on January 26th 2022. In total, 120 individuals are being recruited across 1 site." - Anonymous Online Contributor
Unverified Answer
Are there any current opportunities for participants to join the trial?
"According to the information provided on clinicaltrials.gov, this research is actively enrolling participants. The trial was originally posted on September 25th 2020 and recently updated on January 26th 2022." - Anonymous Online Contributor
Unverified Answer
What conditions typically require a course of Finasteride?
"Finasteride is a common medication for treating androgenetic alopecia, as well as benign prostatic hyperplasia, hirsutism, and polycystic ovary syndrome." - Anonymous Online Contributor
Unverified Answer