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Bicalutamide + BCG for Bladder Cancer (BicaBCa Trial)
Phase 2
Recruiting
Led By Wassim Kassouf, MDCM,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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
BicaBCa Trial 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.Check my eligibility
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.See study design
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.
BicaBCa Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged 18 or older.
Select...
My bladder cancer has not spread into the muscle layer.
BicaBCa Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of bladder tumour recurrence
Secondary outcome measures
Evaluation of urinary symptoms
Incidence of tumour progression
Number of tumor recurrences
+2 moreSide effects data
From 2016 Phase 3 trial • 116 Patients • NCT0208525229%
Hot flush
16%
Flushing
12%
Erectile dysfunction
10%
Libido decreased
7%
Fatigue
7%
Dysuria
5%
Headache
5%
Bronchitis
3%
Back pain
2%
Hypertension
2%
Dizziness
2%
Atrial flutter
2%
Deafness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Leuprorelin 11.25 mg
Active Surveillance
BicaBCa 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
Group II: Control ArmActive Control1 Intervention
Induction intravesical Bacille Calmette-Guérin treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bicalutamide
2003
Completed Phase 3
~5330
Find a Location
Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
167 Previous Clinical Trials
106,997 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,607 Total Patients Enrolled
Wassim Kassouf, MDCM,FRCSCPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man aged 18 or older.My liver tests are more than twice the normal limit.My urologist has recommended BCG treatment for me.I have not had a heart attack or been hospitalized for heart failure in the last year.I received gemcitabine, epirubicin, or mitomycin C right after surgery.My bladder cancer has not spread into the muscle layer.I am taking or will take coumadin.My kidney function is low, with an eGFR below 30.I had prostate cancer treated over 5 years ago with no signs of it coming back.Your blood test shows a low level of a type of white blood cell called neutrophils.I have low testosterone or am on hormone therapy for prostate cancer or other conditions.I have received BCG therapy within the last 5 years.I've had bladder treatment with chemo directly into the bladder in the last 5 years.I have had a blood clot in my veins within the last 3 years.My blood pressure is controlled and not above 160 despite treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Bicalutamide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are contributing to this research endeavor?
"Indeed, the clinical trial is currently accepting candidates. Clinicaltrials.gov records reveal that it was first posted on June 23rd 2022 and subsequently updated on July 13th of the same year. The team needs to enroll 160 individuals from 1 medical site."
Answered by AI
Does this clinical trial presently have the capacity to accept participants?
"According to clinicaltrials.gov, this medical experiment is currently accepting applicants. It was first listed on June 23rd 2022 and the last recorded update occurred on July 13th 2022."
Answered by AI
Has Bicalutamide been greenlit by the Food and Drug Administration?
"Due to the lack of evidence on Bicalutamide's efficacy, our team rated its safety as a 2. This is because it has only been tested for safety in Phase 2 trials."
Answered by AI
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