Dutasteride to prevent recurrence of 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
This will see if taking the oral medicine dutasteride can lower the chance that low-grade non-muscle invasive bladder cancer comes back in adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT07420517 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives dutasteride 0.5 mg once daily to adults with histologically confirmed low-grade non-muscle invasive urothelial carcinoma, using separate cohorts for men (n=70) and women (n=25). Treatment is continued until tumor recurrence or for up to two years, and men’s outcomes will be compared to a historical control while the female cohort is focused on feasibility and safety. The study will collect recurrence timing, adherence, and safety data, and participants who recur may opt to continue dutasteride with reasons documented. Women are included to address limited safety data and recruitment feasibility in this population.
Who should consider this trial
Good fit: Adults aged 18 or older with histologically confirmed low-grade non-muscle invasive urothelial carcinoma who are not scheduled for BCG or intravesical chemotherapy are ideal candidates, with men who have partners of child-bearing potential required to use contraception.
Not a fit: Patients scheduled for BCG or intravesical chemotherapy, or those with muscle-invasive or otherwise high-risk disease requiring immediate definitive treatment, are unlikely to benefit from this preventive approach.
Why it matters
Potential benefit: If successful, dutasteride could provide a simple, well-tolerated oral option to reduce recurrences and decrease the need for repeated bladder procedures.
How similar studies have performed: This approach is relatively novel for bladder cancer—preclinical and observational data suggest potential benefit from 5-alpha-reductase inhibition, but prospective randomized evidence is currently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Québec, Quebec
- CHU de Québec - Université Laval — Québec, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Paul Toren Principal Investigator, MD
- Email: Paul.Toren@crchudequebec.ulaval.ca
- Phone: 418 525 4444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.