Background/significance:
Prostate 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.

Objectives:
1. Compare surgical & clinical indices of oncological outcome
2. Examine comprehensively Quality of Life outcomes in both arms
3. Examine psychological, cancer-specific & decision-related distress
4. Compare economic direct, indirect & intangible costs to patients & health service
5. Determine life-expectancy profiles for patients with development of a life

Methods:
200 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 (JY) and all open prostatectomies are being performed by one other surgeon (GC). 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.

Results:
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. To date, 231 men have been randomised (115 in the open arm and 116 in the robotic arm). Seven men have not proceeded to surgery (5 patients in the open arm and 2 in the robotic arm). At the time of submission, 198 patients have had their operations with 26 booked or awaiting dates.

Conclusion:
Both the pilot study of 69 patients and the trial to-date demonstrate that running such a study in a public hospital setting is a possible and practical undertaking. In this presentation some of the difficulties encountered thus far will be discussed.