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OncoMatch/Clinical Trials/NCT07420517

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

Is NCT07420517 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Dutasteride (0.5mg) for bladder cancer.

Phase 2RecruitingPaul TorenNCT07420517Data as of May 2026

Treatment: Dutasteride (0.5mg)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.

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Disease stage

Grade: low grade (or any mix with a low grade component)

low grade non-muscle invasive urothelial carcinoma

Prior therapy

Cannot have received: BCG therapy

Patients who are scheduled to receive BCG therapy or have received BCG therapy within the last 5 years will be ineligible for enrollment.

Cannot have received: intravesical chemotherapy

Exception: single, post-operative (<24h) intravesical chemotherapy (e.g. gemcitabine, epirubicin or mitomycin C) dose

Patients who are scheduled to receive intravesical chemotherapy or have received an induction course of intravesical chemotherapy within the last 5 years will be ineligible for enrollment. Patients who received a single, post-operative (<24h) intravesical chemotherapy (e.g. gemcitabine, epirubicin or mitomycin C) dose are eligible.

Cannot have received: 5-alpha-reductase inhibitor

Patients receiving 5-alpha-reductase inhibitors within the last 2 years are ineligible for enrollment.

Lab requirements

Liver function

Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal will be ineligible. Nonetheless, patients with Gilbert's disease may be accepted in the study.

Cardiac function

Patients with multiple hospital admissions for heart failure within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrolment.

Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal will be ineligible. Nonetheless, patients with Gilbert's disease may be accepted in the study. Patients with multiple hospital admissions for heart failure within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrolment.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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