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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06279260




Registration number
NCT06279260
Ethics application status
Date submitted
19/02/2024
Date registered
28/02/2024
Date last updated
25/04/2024

Titles & IDs
Public title
National Robotics-Assisted Radical Prostatectomy Database
Scientific title
National Robotics Radical Prostatectomy Database: Exploring Learning Curves and Long Term Surgical, Oncological and Patient Reported Outcomes
Secondary ID [1] 0 0
2023.295RMH21343Protocol_V2.0
Universal Trial Number (UTN)
Trial acronym
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
TTo be eligible to participate in this database, an individual must meet all of the
following criteria: (a) Individuals who consent to participate, (b) within the age range of
16 to 90 years, (c) confirmed diagnosis of localized prostate cancer (PCa) and (d) patients
receiving medical attention at hospitals engaged in collaborative efforts with the
designated database.
Minimum age
16 Years
Maximum age
90 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are not eligible to take part in the database: (a) Individuals who have not
undergone robotic surgery for prostatectomy, (b) without a diagnosis of prostate cancer or
(c) who decline to provide consent for the collection of their health information and (d)
under the age of 16 years.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2030
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Healthcare - Melbourne
Recruitment hospital [2] 0 0
E.J Whitten Prostate Cancer Centre, Epworth Healthcare - Melbourne
Recruitment hospital [3] 0 0
St. Vincent's Private Hospital - Melbourne
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2084 - Melbourne
Recruitment postcode(s) [2] 0 0
3002 - Melbourne
Recruitment postcode(s) [3] 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
Other
Name [4] 0 0
Austin Health
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Surgical notes are detailed reports written by surgeons during and after surgeries. These
notes cover everything from the techniques, instruments used, any issues with the surgical
procedure and post-surgical care for the patient. This information is a treasure trove for
researchers because they can study it to understand how surgeries go, what works best, and
how certain treatments affect patients.

By looking closely at these notes, researchers can find patterns and trends, helping them in
understanding what makes surgeries successful and identify the best ways to perform them.
This information is crucial for creating guidelines based on solid evidence. Also, these
surgical notes are a goldmine for looking back at past surgeries to see how they have
affected patients in the long run.

The real power for research comes when we combine these surgical notes within the Electronic
Medical Records (EMR) and research databases. This makes it easy to collect information
systematically, making it simpler for researchers to study a large number of cases.
Unfortunately, not many people have paid attention to this idea for a long time, leading to
big gaps in the data collection.

To address this issue, we aim to create a database that collects information from surgical
notes effortlessly. This includes details about how surgeons are trained and how they
progress. It's important to make sure that doctors work aligns with research - which is the
best way to address data collection issues. This data can also help record different
technical aspects of surgery and different surgeons' learning curve, making it easier to
compare and improve training. Thus, we aim to standardise notes that are the same across
different hospitals conducting robotic-assisted surgeries for prostatectomy.
Trial website
https://clinicaltrials.gov/ct2/show/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
lawrentschuk@gmail.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06279260