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DatabaseRASORNCT06279260

National Robotics-Assisted Radical Prostatectomy Database

An observational study of Database and Prostate Cancer, run by Melbourne Health at 8 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
How many people
10,000 participants
Where
8 sitesAustralia
Study dates
1 Jul 2024to Dec 2050
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nathan Lawrentschuk, MBBS,PhD, FRACS contact

+6193291197

lawrentschuk@gmail.com

Farleigh Reeves, MBBS, PhD contact

+6193291197

Fairleigh.Reeves2@mh.org.au

8 sites in 1 country

Australia8 sites, 8 recruiting
  • Ballarat Health

    Ballarat, Victoria, 3350

    Not yet recruiting
  • Barwon health

    Geelong, Victoria, 3220

    George Mirmilstein

    Not yet recruiting
  • Austin Healthcare

    Melbourne, Victoria, 2084

    Damien Bolton

    Not yet recruiting
  • E.J Whitten Prostate Cancer Centre, Epworth Healthcare

    Melbourne, Victoria, 3002

    Dixon Woon

    Not yet recruiting
  • St. Vincent's Private Hospital

    Melbourne, Victoria, 3002

    Lih-Ming Wong

    Not yet recruiting
  • Western Heath

    Melbourne, Victoria, 3011

    Niall Corcoran

    Not yet recruiting
  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3050

    Marlon Perara

    Not yet recruiting
  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050

    Nathan Lawrentschuk

    Recruiting

Other trials in Australia

About this study

Official title: National Robotics-Assisted Radical Prostatectomy Database: Exploring Learning Curves and Long Term Surgical, Oncological and Patient Reported Outcome Measures (PROMS)

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.

Read more

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.

Read the detailed description

Radical Prostatectomy (RP) is the only surgical option for resectable PCA with evidenced benefit for overall survival [5,6]. Robotic-Assisted Radical Prostatectomy (RARP) is an evolved RP represents a significant advancement in PCa treatment offering better field of vision \& dexterity for the surgeons [7,8,9,10,11] compared to other procedures such as Open Radical Prostatectomy (ORP) and Laparoscopic Radical prostatectomy (LRP).

A meta-analysis [12] of Randomized Control Trials (RCT) and non-randomized studies reported that RARP and LRP were similar in terms of blood loss, catheter indwelling time, overall complication rate, overall positive surgical margin and biochemical recurrence rates. However, quantitative synthesis of non-randomized studies indicated that RARP was associated with better functional and oncological outcomes compared to LRP.

Despite RARP holding promising benefits, it also presents some potential challenges such as:

  1. Learning curve - Surgeons require significant training and experience to become proficient in using robotic systems. This learning curve can impact surgical outcomes, especially in less experienced hands.
  2. Cost - The robotic systems and associated instruments are expensive, leading to higher upfront costs for hospitals. This can translate to higher costs for patients and healthcare systems.
  3. Disparity between private and public sectors: availability of robotic surgery can be limited by geographic and economic factors, potentially leading to disparities in access to advanced surgical option.

A retrospective audit of all RARP procedures performed at high volume centre in Australia highlighted, operating time costs for RARP is $134.16 AUD per minute which costs the patient and the hospital $30, 588.48 AUD per case. The health industry average costs for a RARP procedure is 32,199 AUD per case. A transition point of 65 cases at the industry average will cost up to $2,092,935 AUD to consistent primary outcomes for patients [13]. Surgeon's experience and efficiency become an important determinant of post RARP outcomes. Incorporating assessment protocols and intensive training programs might contribute to better post RARP outcomes [14].

Another Australian study [15] evaluated the ORP versus RARP outcomes at a high-volume centre. Results of the study indicated significantly lower mean Length of Stay (LOS) for RARP compared with ORP (1.2 vs 4.4 days) and a much higher readmission rate after ORP (19%) compared with RARP (2%). Though the study reported evidenced benefits, it also highlighted that case-mix funding model failed to adequately reimburse the public hospitals for RARP when compared with ORP despite efficient use of hospital resources in terms of hospital stay and reduction in costly readmissions.

A massive inequality gap exists between the public and private sectors. A retrospective analysis of Victorian Cancer Registry data found proportion of private patients who underwent radical prostatectomy (44%) was larger than that for public patients (28%). [16] There are fewer robots in the public sector compared to private hospitals hence public patients are offered alternate approaches.

A barrier to the uptake of robotic-assisted surgery (RAS) continues to be the perceived high costs. A lack of detailed costing information has made it difficult for public hospitals in particular to determine whether use of the technology is justified [17]. This inconsistency in approach and lack of detail makes it difficult for local hospital administrators, health ministries and governing bodies to determine whether the costs of the technology are reasonable and worth the ongoing investment, and has the potential to impact on future strategic decision-making.

It is notable, that robust evidence substantiating the advantages of robotic surgery from high volume centres is currently insufficient. The acquisition of high-quality evidence pertaining to surgical techniques poses a formidable challenge [18]. Robust investigations, characterized by substantial scale and comparativeness, are imperative for a comprehensive assessment of the surgical, oncological and Patient reported outcomes along with learning curves of surgeons associated with RARP.

There is an imperative need for the establishment of a population-based database that systematically captures a comprehensive array of surgical operatives, learning curves of surgeons and the patient-reported quality of life measures (PROM). A structured database holds the potential to provide a standardized framework, enabling robust comparative analyses, trend identification, and the formulation of evidence-based guidelines for the individualized management of prostate cancer.

Medical subject headings
Prostatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)
  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

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start1 Jul 2024
  3. Primary completionDec 2050 (estimated)
  4. Study completionDec 2050 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
10,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06279260
Sponsor's protocol ID
104451/2023.295
Acronym
RASOR
Status last verified
Aug 2024
First submitted
19 Feb 2024
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: * 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.

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.

    PubMed 36910896
  • 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.

    PubMed 28591934
  • 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.

    PubMed 36335325
  • 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.

    PubMed 28607497

Questions about this trial

What is this clinical trial studying?

An observational study of Database and Prostate Cancer, run by Melbourne Health at 8 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nathan Lawrentschuk, MBBS,PhD, FRACS (+6193291197, lawrentschuk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06279260, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.

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