around 65 years and most (78%) had a Gleason sum score of 7. All trials were assessed as having low risk of bias.Based on 270 EFS events, the meta-analysis showed no evidence that EFS was improved with ART compared to a policy of SRT (HR=0.95, 95% CI=0.75-1.21, p=0.70), with only a 1% change in 5-year EFS (89% vs. 88%). Results were consistent across trials (heterogeneity p=0.18; I 2 =42%). Although power is limited, we did not see any strong evidence of a difference in the treatment effect according to any of the patient or disease characteristics assessed. InterpretationThis collaborative, and prospectively-designed systematic review and meta-analysis suggests that ART does not improve EFS in men with localised or locally advanced prostate cancer. Until data on long-term outcomes are available, early salvage treatment would seem the preferable treatment policy as it offers the opportunity to spare many men from RT and its associated side-effects.

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Objectives To test the hypothesis that observation with early salvage radiotherapy (SRT) is not inferior to ‘standard’ treatment with adjuvant RT (ART) with respect to biochemical failure in patients with pT3 disease and/or positive surgical margins (SMs) after radical prostatectomy (RP). To compare the following secondary endpoints between the two arms: patient‐reported outcomes, adverse events, biochemical failure‐free survival, overall survival, disease‐specific survival, time to distant failure, time to local failure, cost utility analysis, quality adjusted life years and time to androgen deprivation. Patients and Methods The Radiotherapy – Adjuvant Versus Early Salvage (RAVES) trial is a phase III multicentre randomised controlled trial led by the Trans Tasman Radiation Oncology Group (TROG), in collaboration with the Urological Society of Australia and New Zealand (USANZ), and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). In all, 470 patients are planned to be randomised 1:1 to either ART commenced at ≤4 months of RP (standard of care) or close observation with early SRT triggered by a PSA level of >0.20 ng/mL (experimental arm). Eligible patients have had a RP for adenocarcinoma of the prostate with at least one of the following risk factors: positive SMs ± extraprostatic extension ± seminal vesicle involvement. The postoperative PSA level must be ≤0.10 ng/mL. Rigorous investigator credentialing and a quality assurance programme are designed to promote consistent RT delivery among patients. Results Trial is currently underway, with 258 patients randomised as of 31 October 2013. International collaborations have developed, including a planned meta‐analysis to be undertaken with the UK Medical Research Council/National Cancer Institute of Canada Clinical Trials Group RADICALS (Radiotherapy and Androgen Deprivation In Combination with Local Surgery) trial and an innovative psycho‐oncology sub‐study to investigate a patient decision aid resource. Conclusion On the current evidence available, it remains unclear if ART is equivalent or superior to observation with early SRT.

days respectively. Patients with an immune-related adverse event survived longer than patients with no immune-related adverse event, with a mean of 208 versus 88 days. CyTOF analysis showed patients with a systemic PR after SBRT had a population of CD8+ CD127-Ki-67+ CD45RO+ T cells that correlated with response. Conclusion: The addition of SBRT after progression on immunotherapy resulted in increased PFS, a systemic response rate of 9.52%, and a disease control rate of 57.14%. Improved PFS correlated with an increased TIL score, the presence of an immune-related adverse event, and T cell activation status.

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Introduction Variation in target volume delineation from clinical trial protocols has been shown to contribute to poorer patient outcomes. A clinical trial quality assurance framework can support compliance with trial protocol. Results of the TROG 08.03 RAVES benchmarking exercise considering variation from protocol, inter‐observer variability and impact on dosimetry are reported in this paper. Methods Clinicians were required to contour and plan a benchmarking case according to trial protocol. Geometric pjmirometers including volume, Hausdorff Distance, Mean Distance to Agreement and DICE similarity coefficient were analysed for targets and organs at risk. Submitted volumes were compared to a STAPLE and consensus ‘reference’ volume for each structure. Dosimetric analysis was performed using dose volume histogram data. Results Benchmarking exercise submissions were received from 96 clinicians. In total 205 protocol variations were identified. The most common variation was inadequate contouring of the CTV in 84/205 (41%). The CTV volume ranged from 65.3 to 193.1 cm3 with a median of 113.2 cm3. The most common dosimetric protocol variation related to rectal dosimetry. The mean submitted rectal volume receiving 40 Gy and 60 Gy, respectively, was 56.14% ± 5.55% and 30.25% ± 6.15%. When corrected to the protocol defined length the mean rectal volume receiving 40 Gy was 60.8% ± 7.92%, while the volume receiving 60 Gy was 33.86% ± 8.21%. Conclusion Variations from protocol were found in the RAVES benchmarking exercise, most notably in CTV and rectum delineation. Inter‐observer variability was evident. Incorrect delineation of the rectum impacted on dosimetric compliance with protocol.

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