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

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ClinicalTrials.gov Identifier: NCT05327647
Recruitment Status : Recruiting
First Posted : April 14, 2022
Last Update Posted : March 13, 2023
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Muscle Invasive Bladder Cancer Drug: Bicalutamide Biological: Control Arm Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
Actual Study Start Date : June 23, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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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 Name: Nonsteroidal antiandrogen
Active Comparator: Control Arm
Induction intravesical Bacille Calmette-Guérin treatment
 Biological: Control Arm
Induction BCG


Outcome Measures
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Primary Outcome Measures :
  1. Rate of bladder tumour recurrence [ Time Frame: 3 years ]
    To time to bladder tumor recurrence compared to the standard of care induction BCG


Secondary Outcome Measures :
  1. Incidence of tumour progression [ Time Frame: 3 years ]
    To compare the incidence of tumor progression between the intervention and control arms

  2. Number of tumor recurrences [ Time Frame: 3 years ]
    To compare the overall incidence of tumor recurrences between intervention and control arms

  3. Number of tumours at first recurrence [ Time Frame: 3 years ]
    Evaluation of the number of tumours at first recurrence between the two arms

  4. 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

  5. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05327647


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

Locations
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Canada, Quebec
Centre Hospitalier de l'Université De Montréal_CHUM Recruiting
Montréal, Quebec, Canada, H2X 3E4
Contact: Jean-Baptiste Lattouf, MD         
McGill University Health Centre_CUSM Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Wassim Kassouf, MDCM    (514) 934-8246    wassim.kassouf.med@ssss.gouv.qc.ca   
Canada
CHU de Québec-Université Laval Recruiting
Québec, Canada, G1G 5X1
Contact: Paul Toren, MD    418-525-4444 ext 17064    Paul.toren@crchudequebec.ulaval.ca   
Contact: Typhaine Gris, PhD    418 525-4444 ext 20417    typhaine.gris@crchudequebec.ulaval.ca   
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Institutes of Health Research (CIHR)
Investigators
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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)
More Information
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Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT05327647    
Other Study ID Numbers: MP-20-2022-6318
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by CHU de Quebec-Universite Laval:
Bicalutamide
BCG instillation
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
 Male Urogenital Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bicalutamide
Androgen Antagonists
Nonsteroidal Anti-Androgens
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents