National Robotics-Assisted Radical Prostatectomy Database (RoPCa-ND)

National Robotics Radical Prostatectomy Database: Exploring Learning Curves and Long Term Surgical, Oncological and Patient Reported Outcomes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer; Learning Curve; Patient Reported Outcome Measures; Oncological Outcomes; Database; Robotic-assisted Radical Prostatectomy; Surgical Outcomes

Detailed Description

The present study aims to model integration of clinical workflow data from Electronic Medical Records (EMR) to a research database using REDCap platform to enhance Prostate Cancer (PCa) research.

The objectives of the Victorian Robotic-assisted Radical Prostatectomy database are:

1. Collect functional outcomes from the PROMs, using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire at baseline (pre-surgery), 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.

2. Gather detailed insights into surgical measures in terms of demographics, operative and post-operative characteristics.

   1. Operative characteristics will include: Protein-Specific Antigen (PSA) at surgery, surgery Gleason score, International Society of Urological Pathologists (ISUP) grade group, pathological T score, scans at surgery, amount of blood loss, operation duration, type of anesthesia, survival status, mortality, surgical margins and pain score.
   2. Post-operative characteristics will include: length of hospital stay, duration of catheter use, complications (if any) and reasons of readmission (if any).
3. Collect the oncological measures in terms of biochemical recurrence and margin status.
4. Track the progress of surgeons learning curve by comparing the surgeons' training data with Patient Reported Outcome Measures (PROM).

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Nathan Lawrentschuk, MBBS,PhD, FRACS; Phone Number: +6193291197; Email: lawrentschuk@gmail.com
• Study Contact Backup: Name: Farleigh Reeves, MBBS, PhD; Phone Number: +6193291197; Email: Fairleigh.Reeves2@mh.org.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3050
      • Royal Melbourne Hospital
      • Contact: Nathan Lawrentschuk
    • Melbourne, Victoria, Australia, 3050
      • Peter Maccallum Cancer Centre
      • Contact: Marlon Perara
    • Melbourne, Victoria, Australia, 2084
      • Austin Healthcare
      • Contact: Damien Bolton
    • Melbourne, Victoria, Australia, 3002
      • E.J Whitten Prostate Cancer Centre, Epworth Healthcare
    • Melbourne, Victoria, Australia, 3002
      • St. Vincent's Private Hospital
      • Contact: Lih-Ming Wong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The database will entail recruitment of retrospective and prospective patient cohorts to collect and analyse data. Retrospective data from the last five years will be obtained from the medical records. Prospective data will be collected from each participating site.

Description

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.

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Standardize notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy.	At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported quality of life outcome measures	The first set of outcome variables will be the functional outcomes from the PROMs, using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire	At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
Surgical	The second set of outcome variables will gather detailed insights into surgical measures in In terms of operative and post-operative characteristics.	At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
Oncological	The third set of outcome variables will collect the oncological measures in terms of Biochemical re-occurrence and margin status.	4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.

Collaborators and Investigators

• Sponsor: Melbourne Health
• Collaborators: Austin Health; Peter MacCallum Cancer Centre, Australia; St Vincent's Hospital; Epworth Healthcare

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2023.295RMH21343Protocol_V2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No