A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bicalutamide, Control Arm.
- Who it may be relevant to
- Registry conditions: Non-Muscle Invasive Bladder Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
Overview
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.
Interventions
- Drug Bicalutamide
Induction intravesical BCG with bicalutamide 150 mg for 90 days - Biological Control Arm
Induction BCG
Primary outcome measures
- Rate of bladder tumour recurrence [Time frame: 3 years]
Secondary outcome measures (5)
- Incidence of tumour progression [Time frame: 3 years]
- Number of tumor recurrences [Time frame: 3 years]
- Number of tumours at first recurrence [Time frame: 3 years]
- Quality of life (QLQ-C30) [Time frame: 3 years]
- Evaluation of urinary symptoms [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Males, age 18 or greater.
- Patients with histologically confirmed non-muscle invasive urothelial carcinoma.
- Patients have been recommended for a course of intravesical BCG induction treatment by their urologist
- Patients who received gemcitabine, epirubicin or mitomycin C instillations immediately post-operatively will be eligible for enrollment.
- 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
- Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrolment.
- 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.
- 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.
- 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.
- 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.
- 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.
- Patients taking an investigational drug within 2 weeks of enrolment into this study will be ineligible.
- Patients receiving or planning to receive coumadin therapy will be ineligible.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 7 centers
- London Health Sciences Centre — London
- University Health Network, Princess Margaret Cancer Centre — Toronto
- Centre intégré de santé et services sociaux de Chaudière Appalaches — Lévis
- Centre Hospitalier de l'Université De Montréal_CHUM — Montreal
- McGill University Health Centre_CUSM — Montreal
- CHU de Québec-Université Laval — Québec
- CIUSSS de l'Estrie - CHUS — Sherbrooke
Identifiers
NCT: NCT05327647 · MP-20-2022-6318