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

NCT07420517 | Recruiting Phase 2 DMC

• 1 other identifier: MP-20-2026-8412
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

recurrence; 5-alpha-reductase inhibitor; Low-grade bladder cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of NMIBC recurrences in patients treated with dutasteride

  To facilitate historical comparisons, a pathologic definition of recurrence is selected. Thus, investigators will be mandated to perform confirmatory biopsies or surgical resection of recurrences. For the female population, recruitment will be compared to the male population based on the established 1:3 ratio of female to male patients.

  From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first

Secondary Outcomes (8)

• Time to surgery

  From enrolment until surgery for suspected recurrence of bladder cancer or 4 years of extended follow-up, whichever occurs first

• Incidence of tumour progression

  From enrolment until first progression or 4 years of extended follow-up, whichever occurs first

• Number of tumour recurrences:

  From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first

• Number of tumours at recurrence

  From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first

• Concordance of cystoscopic recurrence with pathologic recurrence

  From enrolment until 4 years of extended follow-up, whichever occurs first

Study Arms (1)

Dutasteride 0.5 mg oral treatment daily

EXPERIMENTAL

Participants will receive dutasteride 0.5 mg orally once daily for up to 2 years, or until tumor recurrence. Treatment may be continued after recurrence up to 2 years total, if the patient chooses to continue.

Drug: Dutasteride (0.5mg)

Interventions

Dutasteride (0.5mg) DRUG

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.

Dutasteride 0.5 mg oral treatment daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paul Toren: lead

Study Sites (1)

CHU de Québec - Université Laval

Québec, Quebec, G1G 5X1, Canada

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Recurrence

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Paul Toren Principal Investigator, MD

CONTACT

418 525 4444; Paul.Toren@crchudequebec.ulaval.ca

Marjorie Besançon, PhD

CONTACT

418 525 4444; marjorie.besancon@crchudequebec.ulaval.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will therefore include two separate cohorts of men (n=70) and women (n=25).

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 19, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): April 2, 2030
• Study Completion (Estimated): April 2, 2032
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CA (1)