Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy (JCOG0401)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 34
- 主要终点
- time to treatment failure (TTF) of bicalutamide
研究概览
简要总结
The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for PSA failure after radical prostatectomy.
详细描述
A randomized controlled trial is conducted in Japan to evaluate radiotherapy followed by endocrine therapy for PSA failure after radical prostatectomy. Patients who have PSA failure after radical prostatectomy under a diagnosis of localized prostate cancer (T1-2 N0M0) are randomized into treatment group of either radiotherapy followed by endocrine therapy or endocrine therapy alone. Urologic Oncology Study Group (UOSG) in the JCOG composed of 36 specialized institutions will recruit 200 patients. The primary endpoint is time to treatment failure (TTF) of bicalutamide and secondary endpoints are TTF of protocol treatment, progression free survival, overall survival, adverse events and quality of life (QOL). The Clinical Trial Review Committee of the Japan Clinical Oncology Group (JCOG) approved the protocol on April 13, 2004, and the study was activated on May 17, 2004.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of localized prostate cancer (clinical stage T1-2N0M0) which is treated by radical prostatectomy
- •Pathological stage: pT0/2/3 and pN0/x
- •Serum level of PSA once reached < 0.1 ng/ml after radical prostatectomy and then increased 0.4 ng/ml
- •Serum level of PSA 1.0 ng/ml at entry
- •No clinical recurrence based on abdominal and pelvic computed tomography, and a bone scan
- •No history of chemotherapy or radiation therapy or endocrine therapy for any cancer
- •Ages 20 to 79 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •No blood transfusion within 28 days of entry
- •Sufficient organ function within 28 days of entry
- •Provided written informed consent
排除标准
- •Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- •Mental disease or mental symptoms which would affect participant's decision to participate
- •Continuous medication with steroids (exclude external use of steroids for skin)
- •Ischemic heart disease or arrhythmia which needs medical treatment
- •Poorly controlled hypertension
- •Poorly controlled diabetes mellitus
- •History of cerebral infarction or myocardial infarction within 6 months
- •Liver cirrhosis
- •Interstitial pneumonia which requires ventilation assistance, oxygen inhalation, steroids, or diuretic medicine
研究组 & 干预措施
2
Procedure/Surgery: radiotherapy
干预措施: radiotherapy (Procedure)
1
Drug: endocrine therapy
干预措施: endocrine therapy (Drug)
结局指标
主要结局
time to treatment failure (TTF) of bicalutamide
时间窗: time to treatment failure (TTF) of bicalutamide
次要结局
- patient-reported quality of life(1 year)
- TTF of protocol treatment(TTF of protocol treatment)
- overall survival(overall)
- clinical progression free survival(time to clinical progression)
- adverse events(overall)
研究者
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group