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

Laval University

Status and phase: Enrolling; Phase 2

Conditions: Non-Muscle Invasive Bladder Cancer

Treatments: Biological: Control Arm; Drug: Bicalutamide

Study type: Interventional

Funder types: Other

Identifiers

NCT05327647

MP-20-2022-6318

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Bicalutamide

Experimental group

Description:

Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral bicalutamide for 90 days (in cohort A and cohort B)

Treatment:

Drug: Bicalutamide

Control Arm

Active Comparator group

Description:

cohort A: Induction intravesical Bacille Calmette-Guérin treatment cohort B: Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral placebo for 90 days

Treatment:

Biological: Control Arm