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Trial registered on ANZCTR


Registration number
ACTRN12617000296336
Ethics application status
Approved
Date submitted
20/02/2017
Date registered
24/02/2017
Date last updated
14/06/2019
Date data sharing statement initially provided
1/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Robotic and Open Surgery for Prostate Cancer: A Prospective, Multi-centre, Comparative Study of Functional and Oncological Outcomes
Scientific title
Robotic and Open Surgery for Prostate Cancer: A Prospective, Multi-centre, Comparative Study of Functional and Oncological Outcomes
Secondary ID [1] 291235 0
Nil known
Universal Trial Number (UTN)
U1111-1193-2808
Trial acronym
ROSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 302145 0
Condition category
Condition code
Cancer 301760 301760 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Robot-Assisted Laparoscopic Prostatectomy (RALP) using "da Vinci Xi" (Registered Trademark) Intuitive Surgical Surgical System (average 3-4hrs duration) by participating surgeons at RPAH.
Intervention code [1] 297230 0
Treatment: Surgery
Comparator / control treatment
Open Radical Prostatectomy (ORP) using conventional open surgery (average 3-4hrs duration) by participating surgeons at either CRGH or RPAH.
Control group
Active

Outcomes
Primary outcome [1] 301159 0
To assess pre-operative and post-operative oncological outcomes following Robot-Assisted Radical Prostatectomy (RARP) compared to Open Radical Prostatectomy (ORP) by comparing rates of positive surgical margins, lymph node yield and node involvement, extracapsular extension, seminal vesicle invasion, perineural invasion. These are recorded/ measured using operative specimen pathology results, and evidence of clinical progression/recurrence using biochemical (PSA tests) and imaging (CT scan) evidence.
Timepoint [1] 301159 0
Clinical pathology data will be collected Intraoperatively.
Biochemical recurrence (PSA tests) will be measures at 6 weeks, 3, 6, 9 and 12 months and 5 and 10 years postoperatively.
Recurrence on imaging (CT scan) will be measures at3, 6, 9 and 12 months postoperatively.
Primary outcome [2] 301168 0
To assess pre-operative and post-operative urinary and sexual functional outcomes following Robot-Assisted Radical Prostatectomy (RARP) compared to Open Radical Prostatectomy (ORP) using the patient-reported Expanded Prostate Cancer Index Composite Questionnaire (EPIC) and Index of Erectile Function Questionnaire (IIEF);
Timepoint [2] 301168 0
Pre-operative, 2 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months, 5 years and 10 years postoperative.
Primary outcome [3] 318897 0
To assess pre-operative and post-operative patient-reported Quality of life outcomes following Robot-Assisted Radical Prostatectomy (RARP) compared to Open Radical Prostatectomy (ORP) using the physical and mental functioning domains of the SF-36 V2 questionnaire
Timepoint [3] 318897 0
Pre-operative, 6 weeks, 3 months, 6 months, 12 months, 5 years and 10 years postoperative.
Secondary outcome [1] 331892 0
To prospectively assess differences between RARP and ORP in health economic outcomes using the Healthcare Utilisation Questionnaire and participant inpatient data;
Timepoint [1] 331892 0
Pre-operatively, 6 weeks and 6 months postoperatively.
Secondary outcome [2] 331893 0
To prospectively assess differences between RARP and ORP in treatment decision regret using the Decision Regret Scale (DRS) assessment.

Timepoint [2] 331893 0
3 and 12 months postoperatively.
Secondary outcome [3] 331938 0
To identify anatomic features (such as prostate volume; pelvic volume; urethral length; BMI) on pre-operative imaging by MRI scan and 3D pelvic floor ultrasound which may impact urinary functional outcomes post RARP.
Timepoint [3] 331938 0
Pre-operatively and 12 months postoperatively.
Secondary outcome [4] 331939 0
To identify urinary functional parameters which may impact functional outcomes post RARP by Urodynamic testing and dynamic 3D pelvic floor ultrasound.
Timepoint [4] 331939 0
Pre-operatively and 12 months postoperatively.
Secondary outcome [5] 331940 0
To identify sensory changes in sexual function pre- and post-RALP using Genitosensory Analysis
Timepoint [5] 331940 0
Pre-operatively and 12 months postoperatively.
Secondary outcome [6] 331941 0
To examine the predictive ability of pre- and intra-operative clinical and functional parameters to determine favourable post-operative functional outcomes of RARP. Clinical and functional parameters will be recorded from participant medical records and compared with their post-operative data to find correlations between pre- and intra-operative data and favourable post-operative outcomes.
Timepoint [6] 331941 0
Pre-operatively and 12 months postoperatively.

Eligibility
Key inclusion criteria
1. Adult men aged 18 years and over;
2. Undergoing prostatectomy for prostate cancer at RPA or Concord Hospitals;
3. Clinically suitable for robotic prostatectomy;
4. Cognitively able to give written informed consent for participation;
5. Elective procedure.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient lacks the ability to consent for themselves;
2. Patients unwilling to undergo pre- and post-operative evaluation according to protocol;
3. Patient or tumour factors precluding robotic surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Assignment to Robotic or Open surgery will be determined by the treating surgeon
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Demographic and clinical characteristics of patients who undergo robotic and open prostatectomy will be compared using chi-square tests and Fisher’s test. Perioperative outcomes (e.g. operative time / console time, conversion to open, blood loss, transfusion, complications, Clavien-Dindo grades and inpatient stay data) will be compared between groups using chi-square tests and t tests. Patient reported outcome measures (including symptom scores and quality of life measures) will be scored according to the respective developers’ instructions. The mean change in scores between baseline and 6 weeks, 6 months and 12 months will be compared between participant groups using t tests or Wilcoxon rank sum tests depending on the distribution of the data.

For patients who have a robotic procedure, univariate associations between clinical factors assessed by Urodynamics/imaging and post-operative functional outcomes will be assessed using multivariate regression modelling to identify which factors are statistically significant and independent predictors of functional outcomes. A P <0.05 will be considered as statistically significant. Statistical analyses will be conducted using SPSS statistical software (IBM Corp. SPSS Version16.o, Chicago, SPSS Inc. 2007).

Physical and mental functioning (SF-36v2) at 12 months post procedure is the primary outcome used for sample size calculation. In this prospective cohort study, based on the authors experience and previous published data, assuming that at least 70% of the participants in each group will remain in the study and predicting a moderate effect size of d = 0.5 and type-1 error of 0.05, a total sample size of 562 (i.e. 281 per group) would result in 90% power at 12 months postoperative to reject the null hypothesis.
We will use an uncorrected chi-squared statistic to evaluate this null hypothesis. The sample size was calculated using PS (Power and Sample Size Calculations software – version 3.0).

Recruitment
Recruitment status
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)
NSW
Recruitment hospital [1] 7516 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 7517 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 15342 0
2050 - Camperdown
Recruitment postcode(s) [2] 15341 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 295683 0
Government body
Name [1] 295683 0
Sydney Local Health District
Address [1] 295683 0
Level 11, KGV Building
Missenden Road
Camperdown
NSW
2050

Country [1] 295683 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Level 11, KGV Building
Missenden Road
Camperdown
NSW
2050
Country
Australia
Secondary sponsor category [1] 294546 0
None
Name [1] 294546 0
Address [1] 294546 0
Country [1] 294546 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296992 0
Royal Prince Alfred Hospital Ethics Review Committee
Ethics committee address [1] 296992 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Ethics committee country [1] 296992 0
Australia
Date submitted for ethics approval [1] 296992 0
27/06/2016
Approval date [1] 296992 0
12/09/2016
Ethics approval number [1] 296992 0
HREC/16/RPAH/377; Protocol X16-0294; NEAF (AU/1/2717218

Summary
Brief summary
This study will compare the effect of robotic and open surgery for prostate cancer on functional and oncological outcomes

Who is this study for?
You may be eligible to join this study if you are aged 18 years or above, are undergoing prostatectomy for prostate cancer at RPA or Concord Hospitals and are clinically suitable for robotic prostatectomy.

Study details
Participants will either have robotic assisted laparascopic surgery or conventional open surgery as determined by the treating surgeon.

All participants will undergo tests to determine urinary and erectile function, biopsies to determine oncological outcomes and questionnaires to assess quality of life. These assessments will be conducted pre-operatively, post-operatively and at certain follow-up timepoints up to 10 years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72642 0
Dr Scott Leslie
Address 72642 0
Missenden Medical Centre
Suite 7B
54-60 Briggs St
Camperdown
NSW
2050
Country 72642 0
Australia
Phone 72642 0
+61295191331
Fax 72642 0
Email 72642 0
info@scottleslie.com.au
Contact person for public queries
Name 72643 0
Dr Ruban Thanigasalam
Address 72643 0
Inner West Urology
12 Mary St
Auburn
NSW
2144
Country 72643 0
Australia
Phone 72643 0
+61 2 9643 1223
Fax 72643 0
Email 72643 0
drruban.urology@gmail.com
Contact person for scientific queries
Name 72644 0
Dr Ruban Thanigasalam
Address 72644 0
Inner West Urology
12 Mary St
Auburn
NSW
2144
Country 72644 0
Australia
Phone 72644 0
+61 2 9643 1223
Fax 72644 0
Email 72644 0
drruban.urology@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Researchers who provide a methodologically sound proposal, at the discretion of the Primary Investigator and Trial Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access via secure file, subject to approvals by Principal Investigator and Trial Sponsor with the requirement to sign a data access agreement.
What supporting documents are/will be available?
No other documents available
Summary results
No Results