Radiotherapy and Androgen Deprivation in Combination After Local Surgery. A randomised controlled trial for patients with prostate cancer. - RADICALS

niversity College London0 个研究点目标入组 4,000 人开始时间: 2007年12月10日最近更新: 2020年3月11日

研究概览

暂无简介。

•Patients will be joining one or both randomisations.
•Main inclusion criteria (both randomisations):
•- Patient has undergone radical prostatectomy;
•- Patient has prostatic adenocarcinoma;
•- Patient has given written informed consent.
•Additional Radiotherapy Timing Randomisation inclusion criteria:
•- Post-operative serum PSA is < 0.4ng/ml;
•- It is within 3 months after radical prostatectomy;
•- There is uncertainty, in the opinion of the clinician and patient, regarding the need for immediate post-operative radiotherapy.
•Additional Hormone Therapy Duration Randomisation inclusion criteria:
•- Patient is due to receive post-operative radiotherapy (adjuvant or salvage).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1802
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2164

•Main exclusion criteria (both randomisations):
•- Prior hormone therapy;
•- Prior bilateral orchidectomy;
•- Prior pelvic radiotherapy;
•- Other active malignancy likely to interfere with protocol treatment or follow-up;
•- Known distant metastases from prostate cancer;
•- Neoadjuvant treatment;
•- Hypogonadism (testosterone <50ng/dL).
•Additional Radiotherapy Timing Randomisation exclusion criteria:
•- Post-operative biochemical failure, defined as EITHER two consecutive rises in PSA and final PSA >0.1 ng/ml OR three consecutive rises in PSA;
•- More than 3 months since radical prostatectomy.
•Additional Hormone Therapy Duration Randomisation exclusion criteria:
•- PSA >10ng/ml at the time of randomisation.

发起方

niversity College London