Clinical trial NCT05327647: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Muscle Invasive Bladder Cancer
Keywords: Bicalutamide
BCG instillation
Placebo
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Cancer Research Society
First posted: 2022-04-14
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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 study is composed of two cohort A (open-label, around 40 patients) and B (double-blind, with placebo, around 120 patients).

In the cohort A, 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.

In the cohort B, 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) daily intake of 150mg placebo for 3 months + the standard of care of 6 cycles of intravesical instillation BCG.

The participation in this trial should last 36 months from the screening visit to the last follow-up visit.

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 enrolment.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Patients taking an investigational drug within 2 weeks of enrolment into this study will be ineligible.
8. Patients receiving or planning to receive coumadin therapy will be ineligible.

Primary outcomes:
measure: Rate of bladder tumour recurrence
timeFrame: 3 years
Secondary outcomes:
measure: Incidence of tumour progression
timeFrame: 3 years
measure: Number of tumor recurrences
timeFrame: 3 years
measure: Number of tumours at first recurrence
timeFrame: 3 years
measure: Quality of life (QLQ-C30)
timeFrame: 3 years
measure: Evaluation of urinary symptoms
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Centre
state: Ontario
city: Lévis
country: Canada
facility: Centre intégré de santé et services sociaux de Chaudière Appalaches
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université De Montréal_CHUM
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre_CUSM
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec-Université Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS
state: Quebec
Study officials:
affiliation: CHU de Québec-Université Laval
name: Paul Toren, MD,PhD,FRCSC
role: STUDY_CHAIR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Wassim Kassouf, MDCM,FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre, Victoria Hospital
name: Melissa Huynh, MD,MPH,FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Montréal (CHUM)
name: Jean-Baptiste Lattouf, MD,FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: The Princess Margaret Cancer Foundation
name: Girish Kulkarni, BSc, MD, PhD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: