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

• ClinicalTrials.gov Identifier: NCT05327647
• Recruitment Status: Recruiting
• First Posted: April 14, 2022
• Last Update Posted: February 7, 2024
• Sponsor: CHU de Quebec-Universite Laval
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): CHU de Quebec-Universite Laval

Tracking Information

• First Submitted Date: April 7, 2022
• First Posted Date: April 14, 2022
• Last Update Posted Date: February 7, 2024
• Actual Study Start Date: June 23, 2022
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2022)

Rate of bladder tumour recurrence [ Time Frame: 3 years ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 13, 2022)

• Incidence of tumour progression [ Time Frame: 3 years ]
  To compare the incidence of tumor progression between the intervention and control arms
• Number of tumor recurrences [ Time Frame: 3 years ]
  To compare the overall incidence of tumor recurrences between intervention and control arms
• Number of tumours at first recurrence [ Time Frame: 3 years ]
  Evaluation of the number of tumours at first recurrence between the two arms
• 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
• 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).

Original Secondary Outcome Measures (submitted: April 7, 2022)

• Incidence of tumour progression [ Time Frame: 3 years ]
  To compare the incidence of tumor progression between the intervention and control arms
• Number of tumor recurrences [ Time Frame: 3 years ]
  To compare the overall incidence of tumor recurrences between intervention and control arms
• Number of tumours at first recurrence [ Time Frame: 3 years ]
  Evaluation of the number of tumours at first recurrence between the two arms
• Quality of life (QLQ-C30) [ Time Frame: 3 years ]
  Evaluation of quality of life with QLQ-C30 questionnaire
• Evaluation of urinary symptoms [ Time Frame: 3 years ]
  Evaluation of urinary symptoms with International Prostate Symptom Score (IPSS) questionnaire

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
• Official Title: A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
• 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.

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
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Non-Muscle Invasive Bladder Cancer

Intervention

• Drug: Bicalutamide
  Induction intravesical BCG with bicalutamide 150 mg for 90 days
  Other Name: Nonsteroidal antiandrogen
• Biological: Control Arm
  Induction BCG

Study Arms

• Experimental: Bicalutamide
  Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral bicalutamide for 90 days
  Intervention: Drug: Bicalutamide
• Active Comparator: Control Arm
  Induction intravesical Bacille Calmette-Guérin treatment
  Intervention: Biological: Control Arm

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 7, 2022): 160
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2026
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Paul Toren, MD,PhD,FRCSC; 418-525-4444 ext 17064; paul.toren@crchudequebec.ulaval.ca

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT05327647
• Other Study ID Numbers: MP-20-2022-6318
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: CHU de Quebec-Universite Laval
• Original Responsible Party: Same as current
• Current Study Sponsor: CHU de Quebec-Universite Laval
• Original Study Sponsor: Same as current
• Collaborators: Canadian Institutes of Health Research (CIHR)

Investigators

• Study Chair: Paul Toren, MD,PhD,FRCSC; CHU de Québec-Université 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)

• PRS Account: CHU de Quebec-Universite Laval
• Verification Date: February 2024