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.
The study will therefore include two separate cohorts of men (n=70) and women (n=25). After the screening phase, eligible male and female patients who provide informed consent will receive dutasteride at a dose of 0.5 mg once daily for the duration of the study. All participants will follow the same treatment regimen. Treatment will be continued until tumor recurrence or for up to two years in the absence of recurrence. Prior data suggests a long-term mecanism of action of dutasteride in preventing tumor recurrences. Therefore, in the event of tumor recurrence, patients will be offered the option to continue dutasteride treatment for a total duration of up to two years. The decision to continue or discontinue treatment, as well as the reasons for this decision, will be documented. Regarding analyses, the male cohort is designed to provide the first prospective data on efficacy; data will be compared to a historical control cohort, while also collecting adherence and safety data specific to men with low grade NMIBC. The parallel female cohort is primarily intended to assess feasibility of recruitment and safety. In the published literature and our own institutional data, women represent approximately 25% of patients with low grade NMIBC. Recruitment of female patients is therefore more challenging, compounded in part by the limited safety data available and the absence of demonstrated urinary benefits. Consequently, this cohort aims to determine whether inclusion of women in a subsequent phase 3 study will be feasible and safe.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
95
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.
CHU de Québec - Université Laval
Québec, Quebec, Canada
RECRUITINGIncidence 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.
Time frame: From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first
Time to surgery
Time to surgery under general anesthesia: time from enrolment until surgery for suspected recurrence of bladder cancer
Time frame: From enrolment until surgery for suspected recurrence of bladder cancer or 4 years of extended follow-up, whichever occurs first
Incidence of tumour progression
The proportion of patients who experienced tumor progression at the end of follow-up. Progression is defined as a recurrence with an increase in tumour grade to high grade, or an increase in stage, or the new presence of CIS.
Time frame: From enrolment until first progression or 4 years of extended follow-up, whichever occurs first
Number of tumour recurrences:
This is defined as the number of recurrences per patient.
Time frame: From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first
Number of tumours at recurrence
This is defined as the number of tumors at the recurrence. This information is based on cystoscopic findings at time of the cystoscopy preceding surgical resection or the cystoscopy without anesthesia at which the biopsy indicating recurrence was taken.
Time frame: From enrolment until first recurrence or 4 years of extended follow-up, whichever occurs first
Concordance of cystoscopic recurrence with pathologic recurrence
The proportion of suspected pathologic recurrences which were confirmed urothelial carcinoma on pathologic analysis
Time frame: From enrolment until 4 years of extended follow-up, whichever occurs first
Quality of life assessed by the European Organisation for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire (QLQ) non-muscle invasive bladder cancer questionnaire(NMIBC) module 24
Quality of life will be evaluated with the EORTC QLQ-NMIBC24 questionnaire as a global score (linear transformation to 0-100, higher=better).
Time frame: From enrolment to 24 months (end of treatment)
Urinary symptoms assessed by Bladder Utility Symptom Score (BUSS)
Urinary symptoms will be evaluated using BUSS questionnaire (0-100, higher=better)
Time frame: From enrollment until 2 years (end of treatment)
Urinary symptoms assessed by the Internation Prostate Symptom Score (IPSS) questionnaire
Urinary symptoms will be evaluated using the IPSS(0-35, mild (0-7), moderate (8-19), or severe (20-35)) questionnaire among male patients.
Time frame: From enrollment until 2 years (end of treatment)
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