Abstract
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
Highlights
Prostate cancer is the most common male cancer in the Western world there is ongoing debate about the optimal treatment strategy for localised disease
The 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
Study aims and hypotheses The study aims are to assess the quality of life effects of robotic surgery compared with open prostatectomy; determine the economic costs of robotic versus open prostatectomy with regards to both health sector costs and direct and indirect cost to patients; evaluate life expectancy profiles of patients receiving both forms of prostatectomy
Summary
This research program is addressing key questions of importance by evaluating robotic and open prostatectomy in terms of oncologic parameters, quality of life effects including level of satisfaction, economic costs and overall patient life expectancy; and more broadly by establishing a gold standard for the evaluation of new medical technologies in the clinical treatment of prostate cancer in Australia and internationally. Outputs include evidence to facilitate more effective decision making about surgical treatment for localised prostate cancer and information to support health service planning and development for this rapidly growing patient group. Authors’ contributions RAG developed the study concept and aims and initiated the project. All authors assisted in further development of the protocol. RAG, JY, GC, ND, RC implement the protocol and oversee collection of the data. All authors contributed to the final manuscript
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