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

Gardiner, Robert A., Yaxley, John, Coughlin, Geoff, Dunglison, Nigel, Occhipinti, Stefano, Younie, Sandra, Carter, Rob, Williams, Scott, Medcraft, Robyn J., Bennett, Nigel, Lavin, Martin F. and Chambers, Suzanne K. (2012) A randomised trial of robotic and open prostatectomy in men with localised prostate cancer. BMC Cancer, 12 : 189.1-189.12.

Attached Files (Some files may be inaccessible until you login with your UQ eSpace credentials)
Name Description MIMEType Size Downloads

Author Gardiner, Robert A.
Yaxley, John
Coughlin, Geoff
Dunglison, Nigel
Occhipinti, Stefano
Younie, Sandra
Carter, Rob
Williams, Scott
Medcraft, Robyn J.
Bennett, Nigel
Lavin, Martin F.
Chambers, Suzanne K.
Title A randomised trial of robotic and open prostatectomy in men with localised prostate cancer
Journal name BMC Cancer  (ERA 2012 Listed)    (ERA 2010 Rank B)   Check publisher's open access policy
Publication date 2012-05
Sub-type Article
DOI 10.1186/1471-2407-12-189
Volume number 12
ISSN 1471-2407
Start page 189.1
End page 189.12
Total pages 12
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2013
Language eng
Formatted abstract Background
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.

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 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.

Discussion

The study will provide recommendations about the relative benefits of Robotic and Open Prostatectomy to support informed patient decision making about treatment for localisedprostate cancer; and to assist in treatment services planning for this patient group.

Trial Registration

ACTRN12611000661976
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

 
Versions
Version Filter Type
Citation counts: Google Scholar Search Google Scholar
Access Statistics: 30 Abstract Views, 0 File Downloads  -  Detailed Statistics
Created: Thu, 26 Jul 2012, 13:03:35 EST by Jessica Eldridge on behalf of UQ Centre for Clinical Research