A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 7
- 主要终点
- Rate of bladder tumour recurrence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Bicalutamide
Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral bicalutamide for 90 days (in cohort A and cohort B)
干预措施: Bicalutamide (Drug)
Control Arm
cohort A: Induction intravesical Bacille Calmette-Guérin treatment
cohort B: Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral placebo for 90 days
干预措施: Control Arm (Biological)
结局指标
主要结局
Rate of bladder tumour recurrence
时间窗: 3 years
To time to bladder tumor recurrence compared to the standard of care induction BCG
次要结局
- Number of tumours at first recurrence(3 years)
- Incidence of tumour progression(3 years)
- Quality of life (QLQ-C30)(3 years)
- Number of tumor recurrences(3 years)
- Evaluation of urinary symptoms(3 years)