A randomised trial of robotic and open prostatectomy in men with localised prostate cancer

BMC Cancer

Study Protocol

Sandra Younie¹  Rob Carter¹  Nigel Dunglison²  John Yaxley²  Geoff Coughlin²  Stefano Occhipinti³  Scott Williams⁴  Nigel Bennett⁵  Robyn J Medcraft⁶  Robert A Gardiner⁷  Suzanne Kathleen Chambers⁸  Martin F Lavin⁹ 

[1] Deakin Health Economics, Deakin University, Victoria, Australia;Department of Urology, Royal Brisbane Hospital, Queensland, Australia;Griffith Health Institute, Griffith University, Queensland Victoria, Australia;Peter MacCallum Cancer Centre, Queensland, Australia;University of Queensland Centre for Clinical Research, Royal Brisbane Hospital, Queensland, Australia;University of Queensland Centre for Clinical Research, Royal Brisbane Hospital, Queensland, Australia;Department of Urology, Royal Brisbane Hospital, Queensland, Australia;University of Queensland Centre for Clinical Research, Royal Brisbane Hospital, Queensland, Australia;Department of Urology, Royal Brisbane Hospital, Queensland, Australia;Edith Cowan University Health and Wellness Institute, Edith Cowan University, Western Australia, Australia;University of Queensland Centre for Clinical Research, Royal Brisbane Hospital, Queensland, Australia;Edith Cowan University Health and Wellness Institute, Edith Cowan University, Western Australia, Australia;Griffith Health Institute, Griffith University, Queensland Victoria, Australia;Cancer Council Queensland, Queensland, Australia;University of Queensland Centre for Clinical Research, Royal Brisbane Hospital, Queensland, Australia;Radiation Biology and Oncology Laboratory, Queensland Institute of Medical Research, Victoria, Australia;

关键词: Radical Prostatectomy;    Erectile Function;    Localise Prostate Cancer;    Open Prostatectomy;    Open Radical Prostatectomy;   

DOI  :  10.1186/1471-2407-12-189

 received in 2012-04-05, accepted in 2012-05-15,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundProstate cancer is the most common male cancer in the Western world however there is ongoing debate about the optimal treatment strategy for localised disease. While surgery remains the most commonly received treatment for localised disease in Australia more recently a robotic approach has emerged as an alternative to open and laparoscopic surgery. However, high level data is not yet available to support this as a superior approach or to guide treatment decision making between the alternatives. This paper presents the design of a randomised trial of Robotic and Open Prostatectomy for men newly diagnosed with localised prostate cancer that seeks to answer this question.Methods/design200 men per treatment arm (400 men in total) are being recruited after diagnosis and before treatment through a major public hospital outpatient clinic and randomised to 1) Robotic Prostatectomy or 2) Open Prostatectomy. All robotic prostatectomies are being performed by one surgeon and all open prostatectomies are being performed by one other surgeon. Outcomes are being measured pre-operatively and at 6 weeks and 3, 6, 12 and 24 months post-surgery. Oncological outcomes are being related to positive surgical margins, biochemical recurrence +/− the need for further treatment. Non-oncological outcome measures include: pain, physical and mental functioning, fatigue, summary (preference-based utility scores) and domain-specific QoL (urinary incontinence, bowel function and erectile function), cancer specific distress, psychological distress, decision-related distress and time to return to usual activities. Cost modelling of each approach, as well as full economic appraisal, is also being undertaken.DiscussionThe study will provide recommendations about the relative benefits of Robotic and Open Prostatectomy to support informed patient decision making about treatment for localised prostate cancer; and to assist in treatment services planning for this patient group.Trial registrationACTRN12611000661976

【 授权许可】

CC BY   
© Gardiner et al.; licensee BioMed Central Ltd. 2012