An observational study in Database, Prostate Cancer and Robotic-assisted Radical Prostatectomy, sponsored by Melbourne Health. Recruiting at 8 sites in Australia. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Melbourne Health · Observational
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.
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:
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Melbourne Health is the lead sponsor of 59 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible to participate in this database, an individual must meet all of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Plan to share: 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.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2050, 317 months after the start.
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