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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
1/04/2019
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
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
Secondary ID [1] 253285 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
STREP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 258810 0
Surgical options for treatment 265777 0
Condition category
Condition code
Cancer 258960 258960 0 0
Prostate
Surgery 258961 258961 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257740 0
Treatment: Surgery
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.
Control group
Active

Outcomes
Primary outcome [1] 259816 0
Oncological (positive margin status together with biochemical and imaging evidence of progression)
Timepoint [1] 259816 0
6 weeks post-surgery
Primary outcome [2] 259817 0
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)).
Timepoint [2] 259817 0
At baseline and at 6 weeks, 3 months, 12 months, 24 months, 36 months, 48 months and 60 months after surgery.
Primary outcome [3] 259818 0
Quality of life scores (assessed through patient diaries and self-report measures: Expanded Prostate Cancer Index Composite Questionnaire (EPIC) and SF-36 Health Survey).
Timepoint [3] 259818 0
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.
Secondary outcome [1] 268622 0
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))
Timepoint [1] 268622 0
At baseline and at 6 weeks, 3 months, 12 months, 24 months, 36 months, 48 months and 60 months post-surgery.
Secondary outcome [2] 268623 0
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).
Timepoint [2] 268623 0
2-5 years post-surgery
Secondary outcome [3] 268624 0
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
Timepoint [3] 268624 0
2-5 years post-surgery

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.
Minimum age
35 Years
Maximum age
70 Years
Gender
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 3508 0
4006
Recruitment postcode(s) [2] 3509 0
4029

Funding & Sponsors
Funding source category [1] 258210 0
Charities/Societies/Foundations
Name [1] 258210 0
Cancer Council Queensland - Strategic Research Partnership Grants 2008
Address [1] 258210 0
553 Gregory Terrace
Fortitude Valley Qld 4006
Country [1] 258210 0
Australia
Funding source category [2] 258211 0
Hospital
Name [2] 258211 0
Royal Brisbane & Women's Hospital
Address [2] 258211 0
Butterfield St
Herston Qld 4029
Country [2] 258211 0
Australia
Primary sponsor type
University
Name
University of Queensland Centre for Clinical Research
Address
Level 3, Building 71/918
Royal Brisbane & Women's Hospital
Herston Rd, Herston Qld 4006
Country
Australia
Secondary sponsor category [1] 257381 0
Hospital
Name [1] 257381 0
Royal Brisbane & Women's Hospital
Address [1] 257381 0
Butterfield St
Herston Qld 4029
Country [1] 257381 0
Australia
Secondary sponsor category [2] 257382 0
Charities/Societies/Foundations
Name [2] 257382 0
Cancer Council Queensland
Address [2] 257382 0
553 Gregory Terrace
Fortitude Valley Qld 4006
Country [2] 257382 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260194 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 260194 0
Butterfield St,
Herston Qld 4029
Ethics committee country [1] 260194 0
Australia
Date submitted for ethics approval [1] 260194 0
Approval date [1] 260194 0
16/12/2009
Ethics approval number [1] 260194 0
HREC/09/QRBW/320
HREC/09/320/305 (CAISIS database)
Ethics committee name [2] 260195 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 260195 0
Research & Innovation Division
Cumbrae-Stewart Building (72)
THE UNIVERSITY OF QUEENSLAND QLD 4072
Ethics committee country [2] 260195 0
Australia
Date submitted for ethics approval [2] 260195 0
Approval date [2] 260195 0
10/12/2008
Ethics approval number [2] 260195 0
2006000262
Ethics committee name [3] 260196 0
Clinical and Statewide Services (CaSS) Research Committee
Ethics committee address [3] 260196 0
Block 7, Level 13
Royal Brisbane & Women's Hospital
Butterfield St, Herston QLD 4029
Ethics committee country [3] 260196 0
Australia
Date submitted for ethics approval [3] 260196 0
Approval date [3] 260196 0
13/07/2007
Ethics approval number [3] 260196 0
1995/088B

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32010 0
Prof Robert Gardiner
Address 32010 0
UQCCR, Level 6, Building 71/918 RBWH, Herston QLD 4006
Country 32010 0
Australia
Phone 32010 0
+61 7 3346 6046
Fax 32010 0
+61 7 3207 1205
Email 32010 0
f.gardiner@uq.edu.au
Contact person for public queries
Name 15257 0
Ms Ms Aine Farrell
Address 15257 0
UQCCR, Level 3, Building 71/918
RBWH, Herston Rd, Herston QLD 4006
Country 15257 0
Australia
Phone 15257 0
+61 0412 585 665
Fax 15257 0
+61 7 3346 6100
Email 15257 0
a.farrell@uq.edu.au
Contact person for scientific queries
Name 6185 0
Prof Professor Robert Alexander ('Frank') Gardiner
Address 6185 0
UQCCR, Level 3, Building 71/918
RBWH, Herston Rd, Herston QLD 4006
Country 6185 0
Australia
Phone 6185 0
+61 7 33466046
Fax 6185 0
+61 7 32071205
Email 6185 0
f.gardiner@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
2020-21
Available to whom?
Other researchers at the discretion of the Principal Investigator
Available for what types of analyses?
Further statistical analyses if desired
How or where can data be obtained?
By postal request to the Principal Investigator
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1728 0
Coughlin GD, Yaxley JW, Chambers SK, Occhipinti S, Samaratunga H, Zajdlewicz L, Teloken P, Dunglison N, Williams S, Lavin MF, Gardiner RA. A randomised controlled trial of robot-assisted laparoscopic prostatectomy vs. open radical retropubic prostatectomy: 24-month outcomes. Lancet Oncol. 2018 Jul 12. pii: S1470-2045(18)30357-7. doi: 10.1016/S1470-2045(18)30357-7. [Epub ahead of print]
Attachments [1] 1728 0
Publication date and citation/details [2] 1729 0
Yaxley JW, Coughlin GD, Chambers SK, Dunglison N, Gardiner RA. Assessing robot-assisted laparoscopic prostatectomy - Authors' reply. Lancet. 2017 Feb 25;389(10071):800-801. doi: 10.1016/S0140-6736(17)30508-1.
Attachments [2] 1729 0
Other publications
Have study results been made publicly available in another format?
Yes
Results – basic reporting
Results – plain English summary
No convincing evidence of benefit for one form of surgery over the other as has been demonstrated by the 12 week and 24 month timepoints.