Mirabegron for Enlarged Prostate

Overseen By Premal Patel, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: University of Manitoba

Must not be taking: Anticholinergics, B3 agonists

Disqualifiers: Hypertension, Neurologic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the medication mirabegron, used for overactive bladder, can improve life for men with urinary troubles after Rezum therapy, a treatment for an enlarged prostate. Researchers aim to determine if mirabegron can enhance daily life without causing more side effects than a placebo. Men with a history of an enlarged prostate and frequent urination issues might be suitable for this study. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any anticholinergic or B3 agonist medications to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mirabegron is generally safe and well-tolerated in men. Studies have found it effective for treating symptoms of an overactive bladder, even in men with an enlarged prostate. In these studies, men taking mirabegron did not experience more serious side effects than those taking a placebo (a pill with no active medicine). This suggests that mirabegron is a safe option for managing urinary symptoms in men, which is promising for its use after Rezum therapy for an enlarged prostate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about mirabegron for enlarged prostate because it offers a new mechanism of action compared to current treatments like alpha-blockers and 5-alpha reductase inhibitors. Unlike these traditional medications, which primarily work by relaxing muscles in the prostate or shrinking it, mirabegron is a beta-3 adrenergic agonist that targets the bladder's muscle tone to improve urinary symptoms. This unique approach has the potential to provide relief with possibly fewer side effects, making it a promising option for patients who don't respond well to or can't tolerate existing therapies.

What evidence suggests that mirabegron might be an effective treatment for enlarged prostate?

Research has shown that mirabegron alleviates symptoms of an overactive bladder (OAB) and an enlarged prostate (BPH). One study found it effective for about 77.7% of patients with BPH. Another study confirmed its safety and efficacy for men with OAB, regardless of prostate enlargement. In this trial, participants in one arm will receive a 30-day prescription of mirabegron post-procedure. Additionally, combining mirabegron with tamsulosin has yielded better results for patients with both OAB and BPH in previous studies. Overall, mirabegron has shown promise in improving urinary symptoms and quality of life for men with these conditions. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for men with benign prostatic hyperplasia (enlarged prostate) who have undergone Rezum therapy, a treatment for this condition. Participants should be seeking improved outcomes and quality of life post-surgery. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Prostate volume 30-80cc on any imaging modality

I am over 50 and have significant urinary symptoms.

Qmax between 5 and 15ml/s with minimum voided volume of 125cc

Exclusion Criteria

I have high blood pressure.

Known insensitivity to B3 agonist

I have more than 300ml of urine left in my bladder after peeing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either a placebo or a 30-day prescription of mirabegron post-procedure

4 weeks

1 visit (in-person) immediately post-procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, with symptom scores and uroflow parameters measured

4 weeks

3 visits (in-person) at 1, 2, and 4 weeks post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Mirabegron

Trial Overview The study tests if taking the drug Mirabegron after Rezum surgery helps patients feel better compared to those who don't take it (placebo group). It's a randomized controlled trial, meaning people are put into groups by chance to compare results fairly.

How Is the Trial Designed?

Group I: Mirabegron post procedure Experimental Treatment 1 Intervention

In this arm, patients will receive a 30 day prescription of mirabegron post-procedure.

Group II: Placebo pill post rezum Placebo Group 1 Intervention

Patients in this arm will be given the placebo pill following their procedure.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7818393/

Safety and effectiveness of mirabegron in male patients ... Mirabegron was judged to be an effective treatment for 990/1296 (76.4%) patients without BPH, 1935/2491 (77.7%) patients with BPH + treatment, and 421/538 (78.3 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666168325014247

Efficacy and Safety of Mirabegron in Males with Overactive ... Results showed that mirabegron is effective and safe in male OAB patients, with or without BPE or receiving medications for LUTS management. Patient summary. We ...

3. wjmh.org wjmh.org/DOIx.php?id=10.5534/wjmh.250085

Efficacy and Safety of Mirabegron and Tamsulosin ... Studies have demonstrated that the combination of mirabegron and tamsulosin yields better results in treating patients with OAB and BPH compared ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02757768

NCT02757768 | A Study to Evaluate the Efficacy, Safety, ... The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2020/01240/the_efficacy_and_safety_of_mirabegron_on.30.aspx

The efficacy and safety of mirabegron on overactive ... Conclusions: This analysis demonstrates that mirabegron is an effective and safe treatment for OAB symptoms induced by BPH in men receiving tamsulosin therapy ...

6. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003999

Efficacy and Safety of Vibegron for Persistent Symptoms ... In this trial, vibegron met all primary and secondary end points, and was safe and well tolerated in men with OAB symptoms and pharmacologically treated BPH.