NCT05327647 A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
| NCT ID | NCT05327647 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | CHU de Quebec-Universite Laval |
| Condition | Non-Muscle Invasive Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-06-23 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2022-06-23 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Paul Toren, MD,PhD,FRCSC
STUDY CHAIR
CHU de Québec-Université Laval
Frequently Asked Questions
Who can join the NCT05327647 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Non-Muscle Invasive Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05327647 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05327647 currently recruiting?
Yes, NCT05327647 is actively recruiting participants. Contact the research team at paul.toren@crchudequebec.ulaval.ca for enrollment information.
Where is the NCT05327647 trial being conducted?
This trial is being conducted at London, Canada, Toronto, Canada, Lévis, Canada, Montreal, Canada and 3 additional locations.
Who is sponsoring the NCT05327647 clinical trial?
NCT05327647 is sponsored by CHU de Quebec-Universite Laval. The principal investigator is Paul Toren, MD,PhD,FRCSC at CHU de Québec-Université Laval. The trial plans to enroll 160 participants.
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