National Robotics-Assisted Radical Prostatectomy Database

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279260
• Other study ID #: 2023.295RMH21343Protocol_V2.0
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: December 2030

Study information

• Verified date: April 2024
• Source: Melbourne Health
• Contact: Nathan Lawrentschuk, MBBS,PhD, FRACS
• Phone: +6193291197
• Email: lawrentschuk[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: December 2030
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Database
• Learning Curve
• Patient Reported Outcome Measures
• Prostate Cancer
• Prostatic Neoplasms
• Robotic-assisted Radical Prostatectomy

Locations

Country	Name	City	State
Australia	Austin Healthcare	Melbourne	Victoria
Australia	E.J Whitten Prostate Cancer Centre, Epworth Healthcare	Melbourne	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	St. Vincent's Private Hospital	Melbourne	Victoria

Sponsors (5)

Lead Sponsor	Collaborator
Melbourne Health	Austin Health, Epworth Healthcare, Peter MacCallum Cancer Centre, Australia, St Vincent's Hospital

Country where clinical trial is conducted

Australia, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.