A Phase II Prospective Single-arm Study of Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer
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.
• Patients aged 18 or greater;
• Patients with histologically confirmed low grade non-muscle invasive urothelial carcinoma. Patients with any mix of low- and high-grade urothelial carcinoma remain eligible given the frequent histological heterogeneity and the presence of a low grade component;
• Patients have not been recommended for a course of intravesical BCG or chemotherapy induction treatment by their urologist;
• Male patients with partners of child-bearing potential must agree to 2 acceptable forms of birth control and be continued for at least 6 months after study drug is discontinued.