A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Registration Number
- NCT05327647
- Lead Sponsor
- CHU de Quebec-Universite Laval
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 160
Inclusion Criteria:<br><br> 1. Males, age 18 or greater.<br><br> 2. Patients with histologically confirmed non-muscle invasive urothelial carcinoma.<br><br> 3. Patients have been recommended for a course of intravesical BCG induction treatment<br> by their urologist<br><br> 4. Patients who received gemcitabine, epirubicin or mitomycin C instillations<br> immediately post-operatively will be eligible for enrollment.<br><br> 5. Patients with partners of child-bearing potential must agree to 2 acceptable forms<br> of birth control and be continued for at least 3 months after study drug is<br> discontinued.<br><br>Exclusion Criteria:<br><br> 1. Patients who have received induction BCG therapy within the last 5 years will be<br> ineligible for enrolment.<br><br> 2. Patients with a history of myocardial infarction or hospital admission for heart<br> failure within the previous 12 months or who have unstable cardiovascular status<br> will be ineligible for enrolment.<br><br> 3. Patients who have uncontrolled hypertension (for our purposes, defined as those<br> having a systolic blood pressure > 160 documented on 2 occasions despite appropriate<br> medical therapy) will similarly be ineligible.<br><br> 4. Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase<br> or bilirubin are greater than twice the upper limit of normal will be ineligible.<br><br> 5. Patients with clinical hypogonadism, those on androgen replacement therapy, or those<br> with prostate cancer or other diseases treated with systemic hormonal therapy will<br> be ineligible for study enrolment. Patients receiving 5ARIs will not be excluded.<br><br> 6. Patients who have cancer treatment ongoing or planned in the near future which can<br> be anticipated to decrease their 2-year survival or BCa treatment plan will be<br> ineligible.<br><br> 7. Patients taking an investigational drug within 2 weeks of enrolment into this study<br> will be ineligible.<br><br> 8. Patients receiving or planning to receive coumadin therapy will be ineligible.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of bladder tumour recurrence
- Secondary Outcome Measures
Name Time Method Incidence of tumour progression;Number of tumor recurrences;Number of tumours at first recurrence;Quality of life (QLQ-C30);Evaluation of urinary symptoms