Non-Muscle Invasive Bladder Cancer
Conditions
Keywords
Bicalutamide, BCG instillation, Placebo
Brief summary
This is a phase II randomized controlled clinical trial comparing standard induction BCG versus bicalutamide and standard induction BCG among patients with non-muscle invasive bladder cancer.
Detailed description
Bladder cancer is the second most common urological cancer after prostate cancer. Non-muscle invasive bladder cancer (NIMBC) is the most common form (\ 75%). The standard treatment involves the use of intravesical instillation of bacillus Calmette-Guérin (BCG). Nonetheless, 30-40% of the patients still relapse or progress. Clinical and laboratory research suggests that medications targeting the androgen receptor, such as bicalutamide, combined with the standard treatment with BCG may decrease the recurrence rate of NMIBC. The study is composed of two cohort A (open-label, around 40 patients) and B (double-blind, with placebo, around 120 patients). In the cohort A, the participants will be randomized to either the treatment with 1) daily intake of 150 mg bicalutamide for 3 months overlapping with the 6 cycles of intravesical instillations of BCG or 2) the standard of care of 6 cycles of intravesical instillation BCG. In the cohort B, the participants will be randomized to either the treatment with 1) daily intake of 150 mg bicalutamide for 3 months overlapping with the 6 cycles of intravesical instillations of BCG or 2) daily intake of 150mg placebo for 3 months + the standard of care of 6 cycles of intravesical instillation BCG. The participation in this trial should last 36 months from the screening visit to the last follow-up visit.
Interventions
DRUGBicalutamide
Induction intravesical BCG with bicalutamide 150 mg for 90 days
BIOLOGICALControl Arm
Induction BCG
Sponsors
Canadian Institutes of Health Research (CIHR)
Cancer Research Society
CHU de Quebec-Universite Laval
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
The study started with cohort A (open-label study) for around 40 participants. Then the recruitment in cohort A will stop and the recruitment in cohort B (double-blind, with placebo) will start.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males, age 18 or greater. 2. Patients with histologically confirmed non-muscle invasive urothelial carcinoma. 3. Patients have been recommended for a course of intravesical BCG induction treatment by their urologist 4. Patients who received gemcitabine, epirubicin or mitomycin C instillations immediately post-operatively will be eligible for enrollment. 5. Patients with partners of child-bearing potential must agree to 2 acceptable forms of birth control and be continued for at least 3 months after study drug is discontinued.
Exclusion criteria
1. Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrolment. 2. Patients with a history of myocardial infarction or hospital admission for heart failure within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrolment. 3. Patients who have uncontrolled hypertension (for our purposes, defined as those having a systolic blood pressure \> 160 documented on 2 occasions despite appropriate medical therapy) will similarly be ineligible. 4. 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. 5. Patients with clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with systemic hormonal therapy will be ineligible for study enrolment. Patients receiving 5ARIs will not be excluded. 6. Patients who have cancer treatment ongoing or planned in the near future which can be anticipated to decrease their 2-year survival or BCa treatment plan will be ineligible. 7. Patients taking an investigational drug within 2 weeks of enrolment into this study will be ineligible. 8. Patients receiving or planning to receive coumadin therapy will be ineligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of bladder tumour recurrence | 3 years | To time to bladder tumor recurrence compared to the standard of care induction BCG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of tumour progression | 3 years | To compare the incidence of tumor progression between the intervention and control arms |
| Number of tumor recurrences | 3 years | To compare the overall incidence of tumor recurrences between intervention and control arms |
| Number of tumours at first recurrence | 3 years | Evaluation of the number of tumours at first recurrence between the two arms |
| Quality of life (QLQ-C30) | 3 years | Evaluation of quality of life with QLQ-C30 questionnaire (EORTC Core Quality of Life questionnaire). The scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom |
| Evaluation of urinary symptoms | 3 years | Evaluation of urinary symptoms with International Prostate Symptom Score (IPSS) . questionnaire. The total score can range from 0 to 35 (0 being asymptomatic and 35 being very symptomatic). |
Countries
Canada
Contacts
Primary ContactPaul Toren, MD,PhD,FRCSC
Outcome results
None listed