NCT00554086已完成2 期
Phase 2 Trial of Maximum Androgen Blockade (MAB) Dose Escalation From 50 mg to 150 mg Bicalutamide (Casodex) for Biochemical Failure in Prostate Cancer Patients
Canadian Urology Research Consortium2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Doubling of PSA
研究概览
简要总结
Multi-centre one year trial for patients who have rising PSA while on Casodex 50mg daily dose. Casodex dosage escalated to 150 mg tablet daily. Treatment will be continued until patient demonstrates clinical benefit at one year, PSA progression, toxicity, or withdrawal. Treatment will be continued after one year if patient demonstrates continued clinical benefit.
详细描述
The study will be a national, multicentre, open-label, phase II trial. Patients who have a rising PSA on MAB with bicalutamide 50 mg daily will be dose escalated to MAB with 150 mg bicalutamide daily. Subjects will receive trial treatment for 12 months, or until disease progression, unacceptable toxicity or withdrawal of consent. Open label treatment will be offered thereafter if the subject demonstrates clinical benefit at the end of one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Provision of written informed consent.
- •Men, over 18 years of age, with histologically-confirmed prostate cancer
- •Treatment with Zoladex (goserelin acetate) for greater than 3 months prior to Day 1
- •Serum testosterone level < 50 ng/ml
- •Current treatment with bicalutamide 50 mg daily.**
- •Two consecutive rises in PSA above a nadir value, with the absolute value of the latest PSA > 2.0 ng/ml.
- •Highest PSA level no greater than or equal to 30 ng/ml.
- •Life expectancy of greater than 1 year -
排除标准
- •Patients may not have received prolonged anti-androgen therapy other than with bicalutamide. Patients who have received short term (2 months or less) non-steroidal anti-androgen therapy with an agent other than bicalutamide to block flare are not excluded.*
- •PSA level greater than 30 ng/ml.
- •In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease which would make it undesirable for the patient to participate in the trial.
- •Subjects who have received prior chemotherapy.
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
- •Absolute neutrophil count less than 1.5 x 109/L or platelets less than 100 x 109/L.
- •Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR.
- •Serum creatinine greater than 1.5 times -
结局指标
主要结局
Doubling of PSA
时间窗: one year
次要结局
未报告次要终点
研究者
研究点 (2)
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