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

NCT05327647 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-12-18

No results posted yet for this study

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

Interventions

DRUG

Bicalutamide

Induction intravesical BCG with bicalutamide 150 mg for 90 days

BIOLOGICAL

Control Arm

Induction BCG

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Cancer Research Society

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Paul Toren, MD,PhD,FRCSC · CHU de Québec-Université Laval

  • Wassim Kassouf, MDCM,FRCSC · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Melissa Huynh, MD,MPH,FRCSC · London Health Sciences Centre, Victoria Hospital

  • Jean-Baptiste Lattouf, MD,FRCSC · Centre Hospitalier Universitaire de Montréal (CHUM)

  • Girish Kulkarni, BSc, MD, PhD, FRCSC · The Princess Margaret Cancer Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2026-09-01
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05327647 on ClinicalTrials.gov