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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06279260




Registration number
NCT06279260
Ethics application status
Date submitted
19/02/2024
Date registered
28/02/2024
Date last updated
26/08/2024

Titles & IDs
Public title
National Robotics-Assisted Radical Prostatectomy Database
Scientific title
National Robotics-Assisted Radical Prostatectomy Database: Exploring Learning Curves and Long Term Surgical, Oncological and Patient Reported Outcome Measures (PROMS)
Secondary ID [1] 0 0
104451/2023.295
Universal Trial Number (UTN)
Trial acronym
RASOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Database 0 0
Prostate Cancer 0 0
Robotic-assisted Radical Prostatectomy 0 0
Surgical Outcomes 0 0
Oncological Outcomes 0 0
Patient Reported Outcome Measures 0 0
Learning Curve 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To provide a standardized framework, enabling robust evidence strengthening & analyses, trend identification, and the formulation of evidence-based guidelines for the individualized management of PCa.
Timepoint [1] 0 0
At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
Secondary outcome [1] 0 0
Patient reported quality of life outcome measures
Timepoint [1] 0 0
At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
Secondary outcome [2] 0 0
Surgical
Timepoint [2] 0 0
At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
Secondary outcome [3] 0 0
Oncological
Timepoint [3] 0 0
4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.

Eligibility
Key inclusion criteria
To be eligible to participate in this database, an individual must meet all of the following criteria:

1. Individuals who consent to participate,
2. within the age range of 18 to 90 years,
3. confirmed diagnosis of localized prostate cancer (PCa)
4. patients receiving medical attention at hospitals engaged in collaborative efforts with the designated database.
Minimum age
18 Years
Maximum age
90 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants are not eligible to take part in the database:
2. Individuals who have not undergone robotic surgery for prostatectomy or TP biopsy. ,
3. without a diagnosis of prostate cancer or
4. who decline to provide consent for the collection of their health information
5. Under the age of 18 years.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2050
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Ballarat Health - Ballarat
Recruitment hospital [2] 0 0
Barwon health - Geelong
Recruitment hospital [3] 0 0
Austin Healthcare - Melbourne
Recruitment hospital [4] 0 0
E.J Whitten Prostate Cancer Centre, Epworth Healthcare - Melbourne
Recruitment hospital [5] 0 0
St. Vincent's Private Hospital - Melbourne
Recruitment hospital [6] 0 0
Western Heath - Melbourne
Recruitment hospital [7] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
2084 - Melbourne
Recruitment postcode(s) [4] 0 0
3002 - Melbourne
Recruitment postcode(s) [5] 0 0
3011 - Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Epworth Healthcare
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
St Vincent's Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Austin Health
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Barwon Health
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Ballarat Health Services
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Government body
Name [7] 0 0
Western Health, Australia
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
In Australia, nearly 70 men are diagnosed with Prostate cancer every day. Prostate removal (Radical Prostatectomy) is the proven treatment option to control cancer spread. Most of the prostate removal surgeries are done using robots. Robotic assisted prostate removal surgeries have been invented to minimise the risk of side effects post-surgery. Doctors prefer the robots over open surgery as there are benefits to patients (shorter hospital stays, lesser blood loss and better quality of life) and surgeons (better dexterity, improved field of vision and less pain). However, the cost of the robot outweighs the benefits at present and there is very less information concerning the long-term outcomes for patients.

Studies conducted so far are small scale studies and the results from these studies cannot be generalized to the population at large in Australia. So, there is need for a largescale study that will look at the long-term outcomes and the factors that impact robotic surgeries across the metropolitan and rural hospital sectors.

Hence, this comprehensive database has been setup to collaborate with major hospitals, across metropolitan and rural areas in Australia. Through this database, researchers will be able to explore the diagnostic pathway for Prostate cancer and understand the long-term benefits of robotic surgery through patient reported questionnaires. Outcomes from this database will also help compare the quality of care against other powerhouses of robotic surgery.

Eventually, the database aims to standardize diagnostic pathways and clinical notes that are the same across different hospitals conducting robotic-assisted surgeries for Prostatectomy and improve care for prostate cancer patients across the country.
Trial website
https://clinicaltrials.gov/study/NCT06279260
Trial related presentations / publications
Perera S, Fernando N, O'Brien J, Murphy D, Lawrentschuk N. Robotic-assisted radical prostatectomy: learning curves and outcomes from an Australian perspective. Prostate Int. 2023 Mar;11(1):51-57. doi: 10.1016/j.prnil.2022.10.002. Epub 2022 Oct 29.
Fridriksson JO, Folkvaljon Y, Lundstrom KJ, Robinson D, Carlsson S, Stattin P. Long-term adverse effects after retropubic and robot-assisted radical prostatectomy. Nationwide, population-based study. J Surg Oncol. 2017 Sep;116(4):500-506. doi: 10.1002/jso.24687. Epub 2017 Jun 7.
Tiruye T, O'Callaghan M, Moretti K, Jay A, Higgs B, Santoro K, Boyle T, Ettridge K, Beckmann K. Patient-reported functional outcome measures and treatment choice for prostate cancer. BMC Urol. 2022 Nov 5;22(1):169. doi: 10.1186/s12894-022-01117-1.
Chandrasekar T, Tilki D. Prostate cancer: Comparing quality of life outcomes after prostate cancer treatment. Nat Rev Urol. 2017 Jul;14(7):396-397. doi: 10.1038/nrurol.2017.81. Epub 2017 Jun 13. No abstract available.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nathan Lawrentschuk, MBBS,PhD, FRACS
Address 0 0
Country 0 0
Phone 0 0
+6193291197
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06279260