National Robotics-Assisted Radical Prostatectomy Database

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-90
SponsorMelbourne Health

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

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

Secondary outcomes

1

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

Time frame
At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
2

Surgical

The second set of outcome variables will gather detailed insights into surgical measures in In terms of operative and post-operative characteristics.

Time frame
At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
3

Oncological

The third set of outcome variables will collect the oncological measures in terms of Biochemical re-occurrence and margin status.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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