About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
Surgical
The second set of outcome variables will gather detailed insights into surgical measures in In terms of operative and post-operative characteristics.
Oncological
The third set of outcome variables will collect the oncological measures in terms of Biochemical re-occurrence and margin status.
Sponsors and contacts
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Melbourne Health
Lead sponsor
Peter MacCallum Cancer Centre, Australia
Collaborator
Epworth Healthcare
Collaborator
St Vincent's Hospital
Collaborator
Austin Health
Collaborator
Barwon Health
Collaborator
Ballarat Health Services
Collaborator
Western Health, Australia
Collaborator