Bicalutamide + BCG for Bladder Cancer

(BicaBCa Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Melissa Huynh, MD,MPH,FRCSC

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: CHU de Quebec-Universite Laval

Must be taking: Intravesical BCG

Must not be taking: Coumadin, Investigational drugs

Disqualifiers: Myocardial infarction, Heart failure, Hypertension, Liver disease, others

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain treatments like coumadin or investigational drugs. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Bicalutamide + BCG for bladder cancer?

Research shows that Bacillus Calmette-Guérin (BCG) can help reduce the progression of bladder cancer, although it may have high side effects. This suggests that BCG is effective in treating bladder cancer, which is part of the treatment being studied. ^{1 2 3 4 5}

Is the combination of Bicalutamide and BCG safe for humans?

BCG treatment for bladder cancer is generally safe, with only minor side effects reported. Rarely, it can cause arthritis (joint inflammation), which usually responds well to anti-inflammatory medications. ^{2 4 6 7 8}

What makes the Bicalutamide + BCG treatment unique for bladder cancer?

The Bicalutamide + BCG treatment is unique because it combines BCG, a vaccine originally used to prevent tuberculosis, with Bicalutamide, a drug typically used for prostate cancer, to enhance the immune response against bladder cancer. BCG is already a well-established treatment for non-muscle invasive bladder cancer, known for its ability to prevent tumor recurrence and progression by stimulating the immune system. ^{2 6 9 10 11}

Research Team

Girish Kulkarni, BSc, MD, PhD, FRCSC

Principal Investigator

The Princess Margaret Cancer Foundation

Wassim Kassouf, MDCM,FRCSC

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Paul Toren, MD,PhD,FRCSC

Principal Investigator

CHU de Québec-Université Laval

Jean-Baptiste Lattouf, MD,FRCSC

Principal Investigator

Centre Hospitalier Universitaire de Montréal (CHUM)

Melissa Huynh, MD,MPH,FRCSC

Principal Investigator

London Health Sciences Centre, Victoria Hospital

Eligibility Criteria

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.

Inclusion Criteria

I am a man aged 18 or older.

My urologist has recommended BCG treatment for me.

I received gemcitabine, epirubicin, or mitomycin C right after surgery.

Exclusion Criteria

My liver tests are more than twice the normal limit.

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

Patients taking an investigational drug within 3 weeks of enrollment into this study

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily intake of 150 mg bicalutamide or placebo for 3 months, overlapping with 6 cycles of intravesical instillations of BCG

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

33 months

Treatment Details

Interventions

• Bicalutamide (Antiandrogen)
• Control Arm (Other)

Trial Overview 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.

Participant Groups

Group I: Bicalutamide Experimental Treatment 1 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 Arm Active Control 1 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

Control Arm is already approved in United States, United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as TICE BCG for:

• Bladder cancer

🇺🇸 Approved in United States as TheraCys BCG for:

• Bladder cancer

🇪🇺 Approved in European Union as OncoTICE for:

• Bladder cancer

🇨🇦 Approved in Canada as ImmuCyst for:

• Bladder cancer

🇯🇵 Approved in Japan as BCG Vaccine for:

• Bladder cancer
• Tuberculosis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Centre intégré universitaire de santé et services sociaux du Saguenay-Lac-Saint-Jean Chicoutimi, Canada

University Health Network, Princess Margaret Cancer Centre Toronto, Canada

McGill University Health Centre_CUSM Montréal, Canada

Centre Hospitalier de l'Université De Montréal_CHUM Montréal, Canada

More Trial Locations

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Patients Recruited

110,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1417

Patients Recruited

26,550,000+

Cancer Research Society

Collaborator

Trials

8

Patients Recruited

5,400+

Cancer Research Society

Collaborator

Trials

6

Patients Recruited

650+

References

1. England pubmed.ncbi.nlm.nih.gov

Reduced-dose bacillus Calmette-Guérin (BCG) in an era of BCG shortage: real-world experience from a tertiary cancer centre. [2022] To evaluate the impact of one-third-dose (1/3D) bacillus Calmette-Guérin (BCG) on oncological outcomes in a large cohort of patients with non-muscle-invasive bladder cancer (NMIBC) treated with adequate BCG (as defined by the US Food & Drug Administration (FDA)) in a real-world setting.

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Bacillus Calmette-Guerin for bladder cancer: A protocol of systematic review. [2023] This study will systematically assess the efficacy and safety of Bacillus Calmette-Guerin (BCG) for patients with bladder cancer (BC).

3. Switzerland pubmed.ncbi.nlm.nih.gov

Maintenance Therapy with 3-monthly Bacillus Calmette-Guérin for 3 Years is Not Superior to Standard Induction Therapy in High-risk Non-muscle-invasive Urothelial Bladder Carcinoma: Final Results of Randomised CUETO Study 98013. [2015] Bacillus Calmette-Guérin (BCG) maintenance therapy for 3 yr following BCG induction can reduce the progression of urothelial bladder carcinoma versus BCG induction alone, but is associated with high toxicity.

4. United States pubmed.ncbi.nlm.nih.gov

Moreau Strain Bacillus Calmette-Guérin Low Versus Standard Dose in the Treatment of High-Grade T1 Bladder Cancer: A Retrospective Observational Cohort Study. [2020] To evaluate recurrence, progression, and cancer-specific mortality of high-grade T1 non-muscle-invasive bladder cancer by assessing receipt of a low dose of the underexplored bacillus Calmette-Guérin (BCG) Moreau strain in a retrospective observational cohort study.

5. United States pubmed.ncbi.nlm.nih.gov

Association of Bacillus Calmette-Guerin shortages with bladder cancer recurrence: A single-center retrospective study. [2021] To examine the association between Bacillus Calmette-Guerin (BCG) shortage and bladder cancer recurrence in high-risk non-muscle-invasive bladder cancer (NMIBC) patients.

6. Italy pubmed.ncbi.nlm.nih.gov

Bacillus Calmette-Guerin vaccine and bladder cancer incidence: Scoping literature review and preliminary analysis. [2021] The Bacillus Calmette-Guerin (BCG) vaccine has long been used for the prevention of tuberculosis (TB) around the world. BCG is also used as an immunotherapy agent for the treatment of non-muscle invasive urinary bladder cancer. This scoping literature review and preliminary data analysis aims to summarize the literature correlating infantile BCG vaccination with the incidence of future bladder cancer.

7. England pubmed.ncbi.nlm.nih.gov

BCG immunotherapy--from pathophysiology to clinical practice. [2019] Treatment with Bacillus Calmette-Guérin vaccine is mainly in use for superficial bladder cancer, for which it is given intravesically. Overall, this therapy is safe with only minor side effects. Arthritis secondary to such therapy has been rarely reported and usually responds well to NSAID treatment. The mechanisms leading to such a complication, as well as the clinical data, are discussed.

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

IMMUNOTHERAPY OF BLADDER CANCER. BCG VACCINE: PRINCIPLES OF ACTION, EFFICACY AND SAFETY. [2018] Data on the principles of BCG vaccine action on the cancer of bladder are presented. Probable targets for BCG vaccine are estimated. Efficacy of BCG vaccine in non-muscle invasive cancer of bladder is analyzed. Side effects of BCG vaccine are examined. Possibilities of evaluating BCG vaccine usage at low (sub-therapeutical) doses are discussed. Various approaches to reducing the resistance of bladder cancer with respect to BCG vaccine are considered. The perspectives of bladder cancer immunotherapy are outlined.

9. Australia pubmed.ncbi.nlm.nih.gov

Immunological protection induced by bacillus Calmette-Guérin treatment in a murine bladder tumor model. [2019] It has been previously reported that MBT-2 tumor growth is completely inhibited when mice are inoculated with bacillus Calmette-Guérin (BCG). In this study it was examined whether or not vaccination with a mixture of BCG and MBT-2 cells also induces immunological protection against murine bladder tumors.

10. Netherlands pubmed.ncbi.nlm.nih.gov

Nonpathogenic Mycobacterium brumae Inhibits Bladder Cancer Growth In Vitro, Ex Vivo, and In Vivo. [2022] Bacillus Calmette-Guérin (BCG) prevents tumour recurrence and progression in non-muscle-invasive bladder cancer (BC). However, common adverse events occur, including BCG infections.

11. Netherlands pubmed.ncbi.nlm.nih.gov

A BCG success story: From prevention of tuberculosis to optimal bladder cancer treatment. [2022] BCG remains the most important vaccine for tuberculosis 100 years after its first use, and over the past 4 decades it has become the most widely accepted, effective drug used in the treatment of aggressive localized bladder cancer. This review chronicles the narrow path that led to approval and world-wide acceptance of BCG immunotherapy for bladder cancer while immunotherapy trials in other malignancies were abandoned. Six intravesical instillations of 5x10^8 CFU of BCG weekly after bladder tumor resection, first reported in 1976, is superior to resection alone and resection plus intravesical chemotherapy. Maintenance of effective immune stimulation is surprisingly difficult, but 3 weekly treatments 3, 6, and 12, 18, 24, 30 and 36 months after induction produces further significant reduction in tumor recurrence. This 3 week BCG maintenance schedule alone has reduced disease progression and mortality in multicenter randomized clinical trials. In the new age of immuno-oncology patients with many types of cancer now benefit from immunotherapy, but currently these modern agents are prohibitively expensive for most of the world. In contrast, the low cost and therefore low profitability of BCG has resulted in recurrent shortages that threaten both bladder cancer patients and children at risk for tuberculosis and other serious infections. Humanity has greatly benefited from early 20th century science that developed BCG and the benevolence of doctors Calmette and Guerin who put people over profit and widely shared cultures of the vaccine. The 21st century is bringing new immunotherapies and greatly expanding the types of malignancies that can be treated. Recombinant technology is expected to improve both the efficacy and production of BCG, hopefully expanding the availability of BCG and relieving the recurring supply shortage for both vaccination and cancer therapy.