RecruitingPhase 2NCT05327647

A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer

A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer

Sponsor

CHU de Quebec-Universite Laval

Enrollment

160 participants

Start Date

Jun 23, 2022

Study Type

INTERVENTIONAL

Conditions

Non Muscle Invasive Bladder Cancer

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria5

Males, age 18 or greater.
Patients with histologically confirmed non-muscle invasive urothelial carcinoma.
Patients have been recommended for a course of intravesical BCG induction treatment by their urologist
Patients who received gemcitabine, epirubicin or mitomycin C instillations immediately post-operatively will be eligible for enrollment.
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 Criteria8

Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrolment.
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.
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.
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.
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.
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.
Patients taking an investigational drug within 2 weeks of enrolment into this study will be ineligible.
Patients receiving or planning to receive coumadin therapy will be ineligible.