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Trial registered on ANZCTR
Registration number
ACTRN12611000661976
Ethics application status
Approved
Date submitted
18/04/2011
Date registered
29/06/2011
Date last updated
9/10/2023
Date data sharing statement initially provided
1/04/2019
Date results information initially provided
1/04/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
A Randomised Trial of Robotic and Open Radical Prostatectomy (RP): Integrated Multidisciplinary Studies to Group Patient Management
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Scientific title
A Randomised Trial to Compare Physical Function and Quality of Life Following Robotic versus Open RP: Integrated Multidisciplinary Studies to Group Patient Management
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Secondary ID [1]
253285
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Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
STREP Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate cancer
258810
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Surgical options for treatment
265777
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Condition category
Condition code
Cancer
258960
258960
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0
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Prostate
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Surgery
258961
258961
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
257740
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Treatment: Surgery
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Comparator / control treatment
The control treatment is open radical prostatectomy, using the modified Scardino Technique. The procedure takes approximately 2-4 hours. This will be conducted at the Royal Brisbane & Women's Hospital (RBWH). An information booklet will be provided to the participant outlining expectations for the scheduled operation.
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Control group
Active
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Outcomes
Primary outcome [1]
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Oncological (positive margin status together with biochemical and imaging evidence of progression)
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Assessment method [1]
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Timepoint [1]
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6 weeks post-surgery
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Primary outcome [2]
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Continence and sexual function (assessed through self-report measures: International Prostate Symptom Score Questionnaire (IPSS), International Index of Erectile Function Questionnaire (IIEF), Expanded Prostate Cancer Index Composite Questionnaire (EPIC)).
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Assessment method [2]
259817
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Timepoint [2]
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At baseline and at 6 weeks, 3 months, 12 months, 24 months, 36 months, 48 months and 60 months after surgery.
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Primary outcome [3]
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Quality of life scores (assessed through patient diaries and self-report measures: Expanded Prostate Cancer Index Composite Questionnaire (EPIC) and SF-36 Health Survey).
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Assessment method [3]
259818
0
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Timepoint [3]
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At baseline and at 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months after surgery.
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Secondary outcome [1]
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Psychological distress, cancer-specific distress and clinical recovery assessments (assessed through self-report measures: SF-36 Health Survey, Hospital Anxiety and Depression Scale (HADS), International Prostate Symptom Score (IPSS), International Index of Erectile Function Questionnaire (IIEF), Expanded Prostate Cancer Index Composite Questionnaire (EPIC), Impact of Events Scale (IES))
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Assessment method [1]
268622
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Timepoint [1]
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At 10 years post-surgery
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Secondary outcome [2]
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Short-term and overall costing for robotic and open prostatectomy with regards to both the patient and health provider. Costs such as theatre time, and doctor and ward costs, will be obtained from the hospital. Cost to patients such as travel costs, medication and lost wages will be assessed through self-report (cost diary for patients).
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Assessment method [2]
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Timepoint [2]
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2-5 years post-surgery
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Secondary outcome [3]
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A life expectancy calculator will be developed to identify those men at risk of not benefiting from (open or robotic) radical prostatectomy because of cardiovascular severe morbidity and mortality
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Assessment method [3]
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Timepoint [3]
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2-5 years post-surgery
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Eligibility
Key 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.
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Minimum age
35
Years
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Maximum age
70
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Men will be recruited via the Royal Brisbane & Women's Hospital (RBWH) Urology Outpatient Clinic and urologists' private practices. Eligible men who consent to take part will complete baseline assessment, and be randomly assigned to receive either robotic prostatectomy or open prostatectomy. Allocation concealment will occur, with randomisation being undertaken by the holder of the allocation schedule who is based at the central administration site. Randomisation will be concealed from investigators.
Following randomisation, patients will be notified by mail of their designated surgical procedure, and given an information booklet outlining expectations for their scheduled operation. Patients are then placed on the surgical waitlist at the RBWH and scheduled a procedure as per hospital policy and processes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated table. Eligible participants will be stratified by age (40-49, 50-59, 60-69), prostate size (<=80g, >80g), IPSS (0-7, 8-19, 20-35), and need for lymphadenectomy.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/10/2010
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Actual
23/08/2010
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Date of last participant enrolment
Anticipated
22/09/2014
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Actual
25/11/2014
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Date of last data collection
Anticipated
1/04/2025
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Actual
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Sample size
Target
400
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Accrual to date
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Final
334
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
3508
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4006
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Recruitment postcode(s) [2]
3509
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4029
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Cancer Council Queensland - Strategic Research Partnership Grants 2008
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Address [1]
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553 Gregory Terrace
Fortitude Valley Qld 4006
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Country [1]
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Australia
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Funding source category [2]
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Hospital
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Name [2]
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Royal Brisbane & Women's Hospital
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Address [2]
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Butterfield St
Herston Qld 4029
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Country [2]
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Australia
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Primary sponsor type
University
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Name
University of Queensland Centre for Clinical Research
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Address
Level 3, Building 71/918
Royal Brisbane & Women's Hospital
Herston Rd, Herston Qld 4006
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Royal Brisbane & Women's Hospital
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Address [1]
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Butterfield St
Herston Qld 4029
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Country [1]
257381
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Australia
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Secondary sponsor category [2]
257382
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Charities/Societies/Foundations
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Name [2]
257382
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Cancer Council Queensland
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Address [2]
257382
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553 Gregory Terrace
Fortitude Valley Qld 4006
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Country [2]
257382
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260194
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Royal Brisbane & Women's Hospital Human Research Ethics Committee
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Ethics committee address [1]
260194
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Butterfield St,
Herston Qld 4029
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Ethics committee country [1]
260194
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Australia
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Date submitted for ethics approval [1]
260194
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Approval date [1]
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16/12/2009
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Ethics approval number [1]
260194
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HREC/09/QRBW/320
HREC/09/320/305 (CAISIS database)
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Ethics committee name [2]
260195
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University of Queensland Medical Research Ethics Committee
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Ethics committee address [2]
260195
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Research & Innovation Division
Cumbrae-Stewart Building (72)
THE UNIVERSITY OF QUEENSLAND QLD 4072
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Ethics committee country [2]
260195
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Australia
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Date submitted for ethics approval [2]
260195
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Approval date [2]
260195
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10/12/2008
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Ethics approval number [2]
260195
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2006000262
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Ethics committee name [3]
260196
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Clinical and Statewide Services (CaSS) Research Committee
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Ethics committee address [3]
260196
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Block 7, Level 13
Royal Brisbane & Women's Hospital
Butterfield St, Herston QLD 4029
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Ethics committee country [3]
260196
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Australia
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Date submitted for ethics approval [3]
260196
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Approval date [3]
260196
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13/07/2007
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Ethics approval number [3]
260196
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1995/088B
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
32010
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Prof Robert Gardiner
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Address
32010
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UQCCR, Level 6, Building 71/918 RBWH, Herston QLD 4006
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Country
32010
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Australia
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Phone
32010
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+61 7 3346 6046
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Fax
32010
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+61 7 3207 1205
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Email
32010
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[email protected]
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Contact person for public queries
Name
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Ms Ms Aine Farrell
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Address
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UQCCR, Level 3, Building 71/918
RBWH, Herston Rd, Herston QLD 4006
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Country
15257
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Australia
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Phone
15257
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+61 0412 585 665
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Fax
15257
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+61 7 3346 6100
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Professor Robert Alexander ('Frank') Gardiner
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Address
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UQCCR, Level 3, Building 71/918
RBWH, Herston Rd, Herston QLD 4006
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Country
6185
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Australia
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Phone
6185
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+61 7 33466046
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Fax
6185
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+61 7 32071205
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Email
6185
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
After publication of the trial de-identified data will be available on request, we will provide data relating to underlying results only
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When will data be available (start and end dates)?
2020-21
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Available to whom?
Other researchers at the discretion of the Principal Investigator
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Available for what types of analyses?
Further statistical analyses if desired
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How or where can data be obtained?
By postal request to the Principal Investigator
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
7718
Ethical approval
[email protected]
7719
Study protocol
[email protected]
7720
Statistical analysis plan
[email protected]
7721
Informed consent form
[email protected]
7722
Clinical study report
[email protected]
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Coughlin GD, Yaxley JW, Chambers SK, Occhipinti S,...
[
More Details
]
Study results article
Yes
Yaxley JW, Coughlin GD, Chambers SK, Dunglison N, ...
[
More Details
]
Plain language summary
No
No convincing evidence of benefit for one form of ...
[
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]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study.
2016
https://dx.doi.org/10.1016/S0140-6736%2816%2930592-X
Embase
Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: 24-month outcomes from a randomised controlled study.
2018
https://dx.doi.org/10.1016/S1470-2045%2818%2930357-7
Embase
Harnessing the patient voice in prostate cancer research: Systematic review on the use of patient-reported outcomes in randomized controlled trials to support clinical decision-making.
2020
https://dx.doi.org/10.1002/cam4.3018
Dimensions AI
A randomised trial of robotic and open prostatectomy in men with localised prostate cancer
2012
https://doi.org/10.1186/1471-2407-12-189
N.B. These documents automatically identified may not have been verified by the study sponsor.
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