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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Bicalutamide
  Induction intravesical BCG with bicalutamide 150 mg for 90 days
• Биопрепарат Control Arm
  Induction BCG

Первичные конечные точки

• Rate of bladder tumour recurrence [Срок оценки: 3 years]

Вторичные конечные точки (5)

• Incidence of tumour progression [Срок оценки: 3 years]
• Number of tumor recurrences [Срок оценки: 3 years]
• Number of tumours at first recurrence [Срок оценки: 3 years]
• Quality of life (QLQ-C30) [Срок оценки: 3 years]
• Evaluation of urinary symptoms [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 7 центров

• 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

Идентификаторы

NCT: NCT05327647 · MP-20-2022-6318

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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