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

NCT05327647 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MP-20-2022-6318
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Non-Muscle Invasive Bladder Cancer

Keywords

Bicalutamide; BCG instillation; Placebo

Outcome Measures

Primary Outcomes (1)

• Rate of bladder tumour recurrence

  To time to bladder tumor recurrence compared to the standard of care induction BCG

  3 years

Secondary Outcomes (5)

• Incidence of tumour progression

  3 years

• Number of tumor recurrences

  3 years

• Number of tumours at first recurrence

  3 years

• Quality of life (QLQ-C30)

  3 years

• Evaluation of urinary symptoms

  3 years

Study Arms (2)

Bicalutamide

EXPERIMENTAL

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

Drug: Bicalutamide

Control Arm

ACTIVE COMPARATOR

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

Biological: Control Arm

Interventions

Bicalutamide DRUG

Induction intravesical BCG with bicalutamide 150 mg for 90 days

Also known as: Nonsteroidal antiandrogen

Bicalutamide

Control Arm BIOLOGICAL

Induction BCG

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Cancer Research Society: collaborator

Study Sites (7)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

RECRUITING

Centre intégré de santé et services sociaux de Chaudière Appalaches

Lévis, Quebec, G6V3Z1, Canada

RECRUITING

Centre Hospitalier de l'Université De Montréal_CHUM

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

McGill University Health Centre_CUSM

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

CHU de Québec-Université Laval

Québec, Quebec, G1G 5X1, Canada

RECRUITING

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1H 5H3, Canada

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

bicalutamide; Nonsteroidal Anti-Androgens

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androgen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Paul Toren, MD,PhD,FRCSC

  CHU de Québec-Université Laval

  STUDY CHAIR

• Wassim Kassouf, MDCM,FRCSC

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

  PRINCIPAL INVESTIGATOR

• Melissa Huynh, MD,MPH,FRCSC

  London Health Sciences Centre, Victoria Hospital

  PRINCIPAL INVESTIGATOR

• Jean-Baptiste Lattouf, MD,FRCSC

  Centre Hospitalier Universitaire de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

• Girish Kulkarni, BSc, MD, PhD, FRCSC

  The Princess Margaret Cancer Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Toren, MD,PhD,FRCSC

CONTACT

418-525-4444; paul.toren@crchudequebec.ulaval.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study started with cohort A (open-label study) for around 40 participants. Then the recruitment in cohort A will stop and the recruitment in cohort B (double-blind, with placebo) will start.

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: June 23, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)