None listed
Conditions
Brief summary
This is a phase III single centre randomised controlled trial. The study aims to assess the differential clinical outcomes for 400 patiens undergoing radical prostatectomy (RP) using an open versus robot-assisted laparoscopic surgical technique at the Royal Brisbane & Women's Hospital, Australia. The study targets a number of unresolved issues in relation to RP for prostate cancer. These include the clinical oncological results from both open and robotic approaches in a randomised trial, the quality of life effects fom both treatments, economic costs to funding bodies and individual patients, and evaluates testing for the presence of prostate cancer and the biological aggressiveness of the tumour using prostatic fluid. Data will also be collected to develop an instrument for life expectancy prediction of these patients.
Interventions
The intervention is radical prostatectomy using a robot-assisted laparoscopic surgical technique, the Ohio State University Technique. This is is similar to the classical Montsouris technique but with some variations. The procedure takes approximately 3 hours.
This will be conducted at the Royal Brisbane and Women's Hospital (RBWH). An information booklet will be provided to the participant outlining expectations for the scheduled operation.
Sponsors
University of Queensland Centre for Clinical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Participants must: (1) be newly diagnosed with localised prostate cancer and have chosen surgery as their treatment approach; (2) be able to read and speak English; (3) have no previous history of head injury, dementia or psychiatric illness; (4) have no other concurrent cancer; (5) Have a life expectancy of >= 10 years.
Exclusion criteria
Participants must not have: (1) Evidence of non-localised prostate cancer clinically; (2) Any other malignancy within the past 5 years with the exception of non-melanoma skin cancer; (3) Previous pelvic radiotherapy or major pelvic surgery; (4) A history of poor compliance in clinical trials; (5) Any condition which, in the opinion of the Clinical Investigators, would preclude participation in the study.
Outcome results
None listed