RecruitingPhase 2NCT07420517

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

Sponsor

Paul Toren

Enrollment

95 participants

Start Date

Mar 25, 2026

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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.

Exclusion Criteria9

Patients who are scheduled to receive BCG therapy or have received BCG therapy within the last 5 years will be ineligible for enrollment.
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.
Patients with clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with various forms of hormonal therapy will be ineligible for study enrollment.
Patients receiving 5-alpha-reductase inhibitors within the last 2 years are ineligible for enrollment.
Patients with a history of allergy or severe adverse reaction to finasteride or dutasteride are ineligible for enrollment.
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.
Female patients with child-bearing potential are ineligible for enrollment, which is defined as any female under 50 years of age. Exceptions to this age limit may be permitted on a case-by-case basis by the Principal Investigator, based on documented confirmation that there is no child-bearing potential (such as a female without a uterus).
Patients receiving chronic treatment with potent CYP3A4 inhibitors, including but not limited to ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycine, or ciprofloxacin, are ineligible for participation in the study. Occasional use of CYP3A4 inhibitors such as ciprofloxacin for an infection is not prohibited.

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Interventions

DRUGDutasteride (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.