NCT07420517

Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer

A Phase II Prospective Single-arm Study of Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Paul Toren · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Low grade non-muscle-invasive bladder cancer (NMIBC) often recurs after treatment, requiring repeated surgeries, especially in older patients. These recurrences can cause complications, reduce quality of life, and increase healthcare costs. Currently, there is no well-tolerated preventive treatment routinely used for patients with low-risk disease. This study will evaluate whether dutasteride, an oral medication that blocks androgen activity, can reduce the risk of bladder cancer recurrence. Dutasteride is generally well tolerated and easy to take. The study will also assess its safety in women. The goal of this study is to determine whether dutasteride can provide a simple and effective way to prevent recurrences of low grade non-muscle invasive bladder cancer.

Detailed description

The study will therefore include two separate cohorts of men (n=70) and women (n=25). After the screening phase, eligible male and female patients who provide informed consent will receive dutasteride at a dose of 0.5 mg once daily for the duration of the study. All participants will follow the same treatment regimen. Treatment will be continued until tumor recurrence or for up to two years in the absence of recurrence. Prior data suggests a long-term mecanism of action of dutasteride in preventing tumor recurrences. Therefore, in the event of tumor recurrence, patients will be offered the option to continue dutasteride treatment for a total duration of up to two years. The decision to continue or discontinue treatment, as well as the reasons for this decision, will be documented. Regarding analyses, the male cohort is designed to provide the first prospective data on efficacy; data will be compared to a historical control cohort, while also collecting adherence and safety data specific to men with low grade NMIBC. The parallel female cohort is primarily intended to assess feasibility of recruitment and safety. In the published literature and our own institutional data, women represent approximately 25% of patients with low grade NMIBC. Recruitment of female patients is therefore more challenging, compounded in part by the limited safety data available and the absence of demonstrated urinary benefits. Consequently, this cohort aims to determine whether inclusion of women in a subsequent phase 3 study will be feasible and safe.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Dutasteride (0.5mg)	Dutasteride 0.5 mg orally once daily. Treatment begins after enrollment and continues for 2 years or until tumor recurrence. Patients may opt to continue treatment after recurrence for a total of 2 years.

Timeline

• Start date: 2026-03-25
• Primary completion: 2030-04-02
• Completion: 2032-04-02
• First posted: 2026-02-19
• Last updated: 2026-03-30

Locations

1 site across 1 country: Canada