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

February 6, 2024 updated by: CHU de Quebec-Universite Laval

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Bladder cancer is the second most common urological cancer after prostate cancer. Non-muscle invasive bladder cancer (NIMBC) is the most common form (~ 75%). The standard treatment involves the use of intravesical instillation of bacillus Calmette-Guérin (BCG). Nonetheless, 30-40% of the patients still relapse or progress. Clinical and laboratory research suggests that medications targeting the androgen receptor, such as bicalutamide, combined with the standard treatment with BCG may decrease the recurrence rate of NMIBC.

The participants will be randomized to either the treatment with 1) daily intake of 150 mg bicalutamide for 3 months overlapping with the 6 cycles of intravesical instillations of BCG or 2) the standard of care of 6 cycles of intravesical instillation BCG . The participation to this this trial should last 36 months from the screening visit to the last follow-up visit.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre
        • Contact:
    • Quebec
      • Montréal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université De Montréal_CHUM
        • Contact:
          • Jean-Baptiste Lattouf, MD
      • Montréal, Quebec, Canada, H4A 3J1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males, age 18 or greater.
  2. Patients with histologically confirmed non-muscle invasive urothelial carcinoma.
  3. Patients have been recommended for a course of intravesical BCG induction treatment by their urologist
  4. Patients who received gemcitabine, epirubicin or mitomycin C instillations immediately post-operatively will be eligible for enrollment.
  5. 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.

Exclusion Criteria:

  1. Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrollment.
  2. Patients who have received an induction course of intravesical chemotherapy within the last 5 years will be ineligible for enrollment.
  3. 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 enrollment.
  4. 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.
  5. Patients with a history of venous thrombo-embolism (DVT/PE) within the past 3 years.
  6. 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.
  7. Patients with kidney disease with an estimated glomerular filtration rate (eGFR) < 30 will be ineligible.
  8. Patients with neutropenia (< 3,000/μL) will be ineligible.
  9. Patients with clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with various forms of hormonal therapy will be ineligible for study enrollment. Patients receiving 5-alpha-reductase inhibitors will not be excluded.
  10. Patients who have undergone treatment for any malignancy other than bladder cancer within the past 2 years except for superficial non-melanoma skin cancers.
  11. Patients with prior history of prostate cancer treated by definitive local therapy > 5 years ago will only be eligible if they have had no clinical or biochemical evidence of recurrent prostate cancer.
  12. Patients taking an investigational drug within 3 weeks of enrollment into this study.
  13. Patients receiving or planning to receive coumadin therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bicalutamide
Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral bicalutamide for 90 days
Drug: Bicalutamide
Induction intravesical BCG with bicalutamide 150 mg for 90 days
Other Names:
  • Nonsteroidal antiandrogen
Active Comparator: Control Arm
Induction intravesical Bacille Calmette-Guérin treatment
Biological: Control Arm
Induction BCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of bladder tumour recurrence
Time Frame: 3 years
To time to bladder tumor recurrence compared to the standard of care induction BCG
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of tumour progression
Time Frame: 3 years
To compare the incidence of tumor progression between the intervention and control arms
3 years
Number of tumor recurrences
Time Frame: 3 years
To compare the overall incidence of tumor recurrences between intervention and control arms
3 years
Number of tumours at first recurrence
Time Frame: 3 years
Evaluation of the number of tumours at first recurrence between the two arms
3 years
Quality of life (QLQ-C30)
Time Frame: 3 years
Evaluation of quality of life with QLQ-C30 questionnaire (EORTC Core Quality of Life questionnaire). The scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom
3 years
Evaluation of urinary symptoms
Time Frame: 3 years
Evaluation of urinary symptoms with International Prostate Symptom Score (IPSS) . questionnaire. The total score can range from 0 to 35 (0 being asymptomatic and 35 being very symptomatic).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Study Chair: Paul Toren, MD,PhD,FRCSC, CHU de Quebec-Universite Laval
  • Principal Investigator: 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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-20-2022-6318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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