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Bicalutamide + BCG for Bladder Cancer (BicaBCa Trial)

Phase 2

Recruiting

Led By Girish Kulkarni, BSc, MD, PhD, FRCSC

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males, age 18 or greater

Patients with histologically confirmed non-muscle invasive urothelial carcinoma

Must not have

Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal

Patients with a history of myocardial infarction or hospital admission for heart failure within the previous 12 months or who have unstable cardiovascular status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two treatments for bladder cancer. The first is the standard induction BCG, and the second is bicalutamide and standard induction BCG.

Who is the study for?

This trial is for male patients over 18 with non-muscle invasive bladder cancer who are set to receive BCG treatment. They must not have had BCG or certain chemotherapy within the last 5 years, no recent severe heart issues, thromboembolism, significant liver/kidney disease, neutropenia, hypogonadism or prostate cancer treatments (unless stable for >5 years). Participants with reproductive partners must use two birth control methods during and for 3 months post-trial.

What is being tested?

The study compares standard induction Bacillus Calmette-Guérin (BCG) therapy alone versus combined with bicalutamide in treating bladder cancer. It's a phase II trial where participants are randomly assigned to either continue only with their scheduled BCG treatment or to take bicalutamide alongside it.

What are the potential side effects?

Bicalutamide can cause breast pain/enlargement, hot flashes, gastrointestinal disturbances like nausea and diarrhea, potential liver changes and may increase the risk of heart disease. The side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged 18 or older.

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My bladder cancer has not spread into the muscle layer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver tests are more than twice the normal limit.

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I have not had a heart attack or been hospitalized for heart failure in the last year.

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I am taking or will take coumadin.

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My kidney function is low, with an eGFR below 30.

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I have received BCG therapy within the last 5 years.

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I have had a blood clot in my veins within the last 3 years.

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My blood pressure is controlled and not above 160 despite treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of bladder tumour recurrence

Secondary study objectives

Evaluation of urinary symptoms

Incidence of tumour progression

Number of tumor recurrences

+2 more

Side effects data

From 2016 Phase 3 trial • 116 Patients • NCT02085252

29%

Hot flush

16%

Flushing

12%

Erectile dysfunction

10%

Libido decreased

Fatigue

Dysuria

Headache

Bronchitis

Back pain

Atrial flutter

Dizziness

Hypertension

Deafness

100%

80%

60%

40%

20%

Study treatment Arm

Leuprorelin 11.25 mg

Active Surveillance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BicalutamideExperimental Treatment1 Intervention

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

Group II: Control ArmActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Bicalutamide

2003

Completed Phase 3

~6210

0 / 9Eligibility criteria met