Study design of the Medical Therapy of Prostatic Symptoms (MTOPS) trial.
Oliver M Bautista, John W Kusek, Leroy M Nyberg...
https://pubmed.ncbi.nlm.nih.gov/12689743/Actively Recruiting
Led by Beth Israel Deaconess Medical Center · Updated on 2025-10-28
120
Participants Needed
1
Research Sites
21 weeks
Total Duration
Researchers are investigating why some men with Benign Prostatic Hyperplasia BPH, a common condition causing urinary problems due to prostate enlargement, do not respond to the typical treatment drug Finasteride. The study focuses on understanding resistance to this treatment and hopes to use noninvasive methods like MRI to detect prostate inflammation and predict which patients will not benefit from Finasteride, allowing for alternative treatments in the future. Men eligible for the study will receive Finasteride as standard care for BPH symptoms, particularly those with moderate urinary symptoms and a prostate size over 40cc. Participants will undergo prostate MRIs and biopsies, along with blood and urine tests, before starting treatment. They will be monitored every six months with symptom assessments and have follow-up MRIs at three years to track changes in prostate size and inflammation, while tissue samples will be analyzed for gene expression and hormonal levels. Throughout the study, participants will attend clinic visits to evaluate urinary symptoms and treatment response, with a key assessment at 12 months to measure the effect of Finasteride. Researchers will collect detailed data including MRI scans, prostate tissue analyses, and hormone tests to understand treatment resistance. The study aims to improve how BPH is managed by identifying patients unlikely to respond to current therapy, with monitoring continuing over several years to gather comprehensive information.
CONDITIONS
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
Y
Yulia Mulugeta, BS
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Beth Israel Deaconess Medical Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Finasteride in BPH trial | Alpha-blocker (e.g., tamsulosin) as standard care |
|---|---|---|
| What it is | Daily oral finasteride (a 5-alpha-reductase inhibitor) therapy for men with BPH and moderate or greater lower urinary tract symptoms, assessed for response by symptom scores and prostate imaging over time. | Oral alpha-blocker therapy (such as tamsulosin), commonly used as first-line management for men with BPH and lower urinary tract symptoms to improve urinary flow and reduce symptoms. |
| Role in trial | Investigational therapy. All participants in the trial receive finasteride to assess treatment response and study biologic markers associated with resistance. | Not studied in trial, but represents the established first-line treatment for comparable patients with BPH in routine practice. |
| Primary use | To improve lower urinary tract symptoms and potentially reduce prostate size in men with BPH. Also intended to identify markers of resistance to 5ARI therapy. | To relieve lower urinary tract symptoms and improve urinary flow in men with BPH, most effectively for those with mild to moderate prostate enlargement. |
| How it is given or performed | Finasteride is taken orally, once daily. Participants are monitored every 6 months for symptom changes and undergo MRI and biomarker evaluations at specified intervals. | Alpha-blockers are also taken orally, once daily, at a recommended dose for symptom management. Regular follow-up is typically needed to assess response. |
| Evidence status | The current study is ongoing and will evaluate changes in urinary symptoms and biologic markers as outcomes. Published literature has previously demonstrated finasteride can reduce symptoms and prostate size for many men, though some patients experience limited response. | Extensive published evidence demonstrates that alpha-blockers improve urinary symptoms in BPH and are recommended as the initial management for most men with moderate symptoms. |
| Important limitations | Not every patient with BPH responds to finasteride. The study seeks to clarify mechanisms of resistance but findings may not immediately generalize beyond the monitored population. Known published limitations include a delayed onset of action and potential for sexual side effects. | Alpha-blockers relieve symptoms but do not shrink the prostate or reduce the risk of urinary retention or surgery. Effectiveness may be less for men with larger prostates. Side effects, though generally mild, can include low blood pressure and dizziness. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants who are eligible will begin treatment with Finasteride for management of benign prostatic hyperplasia symptoms. They will have prostate MRIs and biopsies, and blood and urine samples collected to assess gene expression, methylation patterns, and hormone levels.
Clinic visits every 6 months with assessment of urinary symptoms; MRI at start and 3 years
Duration - Up to 3 years
Participants will be monitored for changes in prostate size and symptom improvement with an MRI at the 3-year time point to assess long-term effects and inflammatory changes.
1 MRI visit at 3 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor