Actively Recruiting
Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer
Led by Paul Toren · Updated on 2026-03-30
95
Participants Needed
1
Research Sites
314 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 or greater
- Histologically confirmed low grade non-muscle invasive urothelial carcinoma, including mixed low- and high-grade tumors
- No recommendation for intravesical BCG or chemotherapy induction treatment by their urologist
- Male patients with partners of child-bearing potential must agree to use two acceptable forms of birth control during and for 6 months after treatment
You will not qualify if you...
- Scheduled to receive or received BCG therapy within the last 5 years
- Scheduled to receive or received induction intravesical chemotherapy within the last 5 years (except a single post-operative dose within 24 hours)
- Clinical hypogonadism, androgen replacement therapy, prostate cancer, or other hormonal therapy
- Use of 5-alpha-reductase inhibitors within the last 2 years
- History of allergy or severe reaction to finasteride or dutasteride
- Liver disease with elevated liver enzymes more than twice the upper limit of normal (except Gilbert's disease)
- Multiple hospital admissions for heart failure in last 12 months or unstable cardiovascular status
- Female patients under 50 years of age with child-bearing potential (exceptions possible if no child-bearing potential documented)
- Chronic treatment with potent CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, verapamil)
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Québec - Université Laval
Québec, Quebec, Canada, G1G 5X1
Actively Recruiting
Research Team
P
Paul Toren Principal Investigator, MD
CONTACT
M
Marjorie Besançon, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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