Method: In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, were able to read and speak English, had no previous history of head injury, dementia, or psychiatric illness or no other concurrent cancer, had an estimated life expectancy of 10 years or more, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women's Hospital (Brisbane, QLD). Participants were randomly assigned (1:1) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patient's condition. Further, a masked central pathologist reviewed the biopsy and radical prostatectomy specimens. Primary outcomes were urinary function (urinary domain of EPIC) and sexual function (sexual domain of EPIC and IIEF) at 6 weeks, 12 weeks, and 24 months and oncological outcome (positive surgical margin status and biochemical and imaging evidence of progression at 24 months). The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months. We report here the early outcomes at 6 weeks and 12 weeks. The per-protocol populations were included in the primary and safety analyses. This trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12611000661976.
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Interpretation: These two techniques yield similar functional outcomes at 12 weeks. Longer term follow-up is needed. In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than a specific surgical approach.
Funding: Cancer Council Queensland.
Published Online: 26 July 2016 The Lancet DOI: http://dx.doi.org/10.1016/S0140-6736(16)30592-X © 2016 Elsevier Ltd. All rights reserved.
John W Yaxley, FRACS, Geoffrey D Coughlin, FRACS, Prof Suzanne K Chambers, PhD, Stefano Occhipinti, PhD, Hema Samaratunga, FRCPA, Leah Zajdlewicz, MOrgPsych, Nigel Dunglison, FRACS, Prof Rob Carter, PhD, Scott Williams, MBBS, Diane J Payton, FRCPA, Joanna Perry-Keene, FRCPA, Prof Martin F Lavin, PhD, Prof Robert A Gardiner, AM MD.
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