Trans Tasman Radiation Oncology Group (TROG) 08.03 - A Phase III Multi-Centre Randomised Trial Comparing biochemical failure following Adjuvant Radiotherapy (RT) versus Early Salvage RT in Patients With Positive Margins or Extraprostatic Disease Following Radical Prostatectomy.

Trans Tasman Radiation Oncology Group (TROG)0 个研究点目标入组 333 人开始时间: 2011年7月26日最近更新: 2023年9月12日

适应症

试验速览

暂无简介。

•1. Prior radical prostatectomy (RP) for adenocarcinoma of the prostate. 2. Histological confirmation of adenocarcinoma of the prostate with Gleason score reported (RP specimen). 3. Patients must have at least one of the following risk factors: a) positive margins, b) extraprostatic extension (EPE) with or without seminal vesicle involvement (pT3a or pT3b). 4. Capable of starting RT within 4 months of RP (a requirement if randomised to adjuvant RT arm). 5. Most recent PSA <= 0.1ng/ml following RP and prior to randomisation. 6. European Cooperative Oncology Group (ECOG) performance status 0-1. 7. Patient able to adhere to the specified follow-up schedule and complete the Quality Of Life and anxiety/depression self assessments. 8. Written informed consent obtained prior to randomisation. 9. Completion of all pre-treatment evaluations. 10. 18 years or older.

•1. Previous pelvic RT. 2. Concurrent or previous malignancy 5 years prior to randomisation (except non-melanomatous skin cancer). 3. Androgen deprivation (AD) prior to or following RP. 4. Evidence of nodal or distant metastases. 5. Co-morbidities that would interfere with the completion of treatment or 5 years of follow-up. 6. Concurrent cytotoxic medication. 7. Hip prothesis

发起方

Trans Tasman Radiation Oncology Group (TROG)