A Phase III trial to investigate the timing of radiotherapy for prostate cancer with high-risk features: background and rationale of the Radiotherapy - Adjuvant Versus Early Salvage (RAVES) trial

Maria Pearse, Carol Fraser-Browne, Ian D. Davis, Gillian M. Duchesne, Richard Fisher, Mark Frydenberg, Annette Haworth, Chakiath Jose, David J. Joseph, Tee S. Lim, John Matthews, Jeremy Millar, Mark Sidhom, Nigel A. Spry, Colin I. Tang, Sandra Turner, Scott G. Williams, Kirsty Wiltshire, Henry H. Woo, Andrew Kneebone

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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 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

    Original languageEnglish
    Pages (from-to)7-12
    Number of pages6
    JournalBJU International
    Issue numbersuppl. 2
    Early online date19 Feb 2014
    Publication statusPublished - Mar 2014

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