Adjuvant Radiation Therapy vs. Watchful Waiting in Prostate Cancer Patients With Positive Margins or Capsular Penetration After Radical Prostatectomy
试验速览
- 阶段
- 3 期
- 入组人数
- 250
- 主要终点
- Biochemical disease-free survival
研究概览
简要总结
The purpose of this study is to determine whether adjuvant radiotherapy following radical prostatectomy in prostate cancer patients with positive margins or capsular penetration improves biochemical, overall and/or cancer specific survival and whether adjuvant radiotherapy is reasonably well tolerated when compared to watchful waiting.
详细描述
In this study the investigators will evaluate adjuvant radiation therapy vs. watchful waiting in prostate cancer patients with positive margins or capsular penetration after radical prostatectomy. This is a randomized, open label, multicentre, collaborative study of FinnProstate Group and Finnish Radiation Oncology group.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with pT3aN0M0 or pT2N0M0 prostate cancer with a positive margin, gleason score 2-10, preoperative PSA < 20 ug/l, postoperative PSA <0.5 ug/l after surgery (within 8 weeks), the WHO performance status 0-2, life expectancy at least 3 months, informed consent obtained.
排除标准
- •Other simultaneous cancer therapy including systemic endocrine therapy; more than 12 weeks has elapsed since surgery for prostate cancer; metastatic disease (N+ or M1); cancer invasion to the seminal vesicles; any other previous malignancy within the last 5 years except basalioma or squamous cell carcinoma of the skin; any contraindication to irradiation (severe locoregional infection, prior radiation therapy to the prostate/bladder); any physical or mental condition, which in the opinion of the investigator, may interfere with patient's ability to comply with scheduled visits.
结局指标
主要结局
Biochemical disease-free survival
时间窗: Five years
Overall survival
时间窗: Five years
Cancer specific survival
时间窗: 5 years
次要结局
- Local recurrence verified by needle or surgical biopsy(Five years)
- Adverse events(Five years)
研究者
Teuvo Tammela
M.D., Ph.D., Professor of Surgery
Tampere University Hospital