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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

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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
* Patient data will only be transferred and analysed in a coded form by mentioned investigators.
* Transferring patient data will require host organisation's formal approval
* Individual patients will not be identifiable from the presented or published material.
* The institution and the researcher must comply with all relevant laws and standards in relation to the use of the material.
* The institution and researcher must not use the material for any purpose other than the specified research or other purposes expressly permitted under the terms of the Agreement.
* Data linkage across sites will be set up when necessary. Once linkage has been completed, identifiers will be removed from the data to be used in the research, unless consent has been given for its identifiable use.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06279260