NCT06279260

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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
299mo left

Started Jul 2024

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jul 2024Dec 2050

First Submitted

Initial submission to the registry

February 19, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
26.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2050

Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

26.4 years

First QC Date

February 19, 2024

Last Update Submit

August 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Patient reported quality of life outcome measures

    At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.

  • Surgical

    At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.

  • Oncological

    4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.

Eligibility Criteria

Age18 Years - 90 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales who are diagnosed with localized Prostate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • To be eligible to participate in this database, an individual must meet all of the following criteria:
  • Individuals who consent to participate,
  • within the age range of 18 to 90 years,
  • confirmed diagnosis of localized prostate cancer (PCa)
  • patients receiving medical attention at hospitals engaged in collaborative efforts with the designated database.

You may not qualify if:

  • Participants are not eligible to take part in the database:
  • Individuals who have not undergone robotic surgery for prostatectomy or TP biopsy. ,
  • without a diagnosis of prostate cancer or
  • who decline to provide consent for the collection of their health information
  • Under the age of 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ballarat Health

Ballarat, Victoria, 3350, Australia

NOT YET RECRUITING

Barwon health

Geelong, Victoria, 3220, Australia

NOT YET RECRUITING

Austin Healthcare

Melbourne, Victoria, 2084, Australia

NOT YET RECRUITING

E.J Whitten Prostate Cancer Centre, Epworth Healthcare

Melbourne, Victoria, 3002, Australia

NOT YET RECRUITING

St. Vincent's Private Hospital

Melbourne, Victoria, 3002, Australia

NOT YET RECRUITING

Western Heath

Melbourne, Victoria, 3011, Australia

NOT YET RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3050, Australia

NOT YET RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

RECRUITING

Related Publications (4)

  • 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.

    PMID: 36910896BACKGROUND
  • 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.

    PMID: 28591934BACKGROUND
  • 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.

    PMID: 36335325BACKGROUND
  • 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.

    PMID: 28607497BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Nathan Lawrentschuk, MBBS,PhD, FRACS

CONTACT

Farleigh Reeves, MBBS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 28, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

December 1, 2050

Study Completion (Estimated)

December 1, 2050

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

* 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.

Locations