ISRCTN24991896已完成不适用

A randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer

Medical Research Council (MRC) Clinical Trials Unit - Cancer Division (UK)0 个研究点目标入组 1,200 人开始时间: 2000年4月6日最近更新: 2018年11月12日

适应症

试验速览

•1. Histological diagnosis of adenocarcinoma of the prostate within 6 months of randomisation
•2. Either (a) clinical stage T3 or T4, NO or NX, MO or (b) clinical stage T2, NO or NX, MO with Prostate-Specific Antigen (PSA) greater than 40 or (c) clinical stage T2, NO or NX, MO with PSA greater than 20 and Gleason sum score greater than or equal to 8
•3. The patient must have a bone scan (with X-rays of any areas of abnormal uptake) reported as being free of evidence of bony metastases within 16 weeks prior to randomisation (if not already on hormones) or 16 weeks prior to the start of hormones (if on hormones already)
•4. No previous treatment for prostate cancer apart from transurethral resection. However, the patient may have received prior hormone therapy during the 12 weeks prior to randomisation, provided that (a) a negative bone scan was demonstrated, preferably within the 16 weeks prior to starting hormone therapy but certainly within 2 weeks after starting hormone therapy and (b) baseline PSA within 4 weeks prior to hormone therapy is available
•5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•6. Patients must be less than 80 years old
•7. Written informed consent

•1. A history of previous or concurrent malignancy other than non-melanomatous skin cancer within 5 years of diagnosis of the prostatic cancer.
•2. The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.
•3. Any contraindication to pelvic radiotherapy (e.g. inflammatory bowel disease).
•4. Any serious non-malignant disease resulting in a life expectancy of less than 5 years.

发起方

Medical Research Council (MRC) Clinical Trials Unit - Cancer Division (UK)