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Retzius-sparing versus standard robotic-assisted laparoscopic prostatectomy for the treatment of clinically localized prostate cancer.

ABSTRACT:

SUBMITTER: Rosenberg JE

PROVIDER: S-EPMC7437391 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Retzius-sparing versus standard robotic-assisted laparoscopic prostatectomy for the treatment of clinically localized prostate cancer.

Rosenberg Joel E JE Jung Jae Hung JH Edgerton Zach Z Lee Hunju H Lee Solam S Bakker Caitlin J CJ Dahm Philipp P

The Cochrane database of systematic reviews 20200818

<h4>Background</h4>Robotic-assisted laparoscopic prostatectomy (RALP) is widely used to surgically treat clinically localized prostate cancer. It is typically performed using an approach (standard RALP) that mimics open retropubic prostatectomy by dissecting the so-called space of Retzius anterior to the bladder. An alternative, Retzius-sparing (or posterior approach) RALP (RS-RALP) has been described, which is reported to have better continence outcomes but may be associated with a higher risk ...[more]

PMID: 32813279

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Project description:ImportanceThe cost-effectiveness of different surgical techniques for radical prostatectomy remains a subject of debate. Emergence of recent critical clinical data and changes in surgical equipment costs due to their shared use by different clinical specialties necessitate an updated cost-effectiveness analysis in a centralized, largely government-funded health care system such as the UK National Health Service (NHS).ObjectiveTo compare robotic-assisted radical prostatectomy (RARP) with open radical prostatectomy (ORP) and laparoscopic-assisted radical prostatectomy (LRP) using contemporary data on clinical outcomes, costs, and surgical volumes in the UK.Design, setting, and participantsThis economic analysis used a Markov model developed to compare the cost-effectiveness of RARP, LRP, and ORP to treat localized prostate cancer. The model was constructed from the perspective of the UK NHS. The model simulated 65-year-old men who underwent radical prostatectomy for localized prostate cancer and were followed up for a 10-year period. Data were analyzed from May 1, 2020, to July 31, 2021.ExposuresRobotic-assisted radical prostatectomy, LRP, and ORP.Main outcomes and measuresQuality-adjusted life-years (QALYs), costs (direct medical costs and costs outside the NHS), and incremental cost-effectiveness ratios (ICERs).ResultsCompared with LRP, RARP cost £1785 (US $2350) less and had 0.24 more QALYs gained; thus, RARP was a dominant option compared with LRP. Compared with ORP, RARP had 0.12 more QALYs gained but cost £526 (US $693) more during the 10-year time frame, resulting in an ICER of £4293 (US $5653)/QALY. Because the ICER was below the £30 000 (US $39 503) willingness-to-pay threshold, RARP was more cost-effective than ORP in the UK. The most sensitive variable influencing the cost-effectiveness of RARP was the lower risk of biochemical recurrence (BCR). Scenario analysis indicated RARP would remain more cost-effective than ORP as long as the BCR hazard ratios comparing RARP vs ORP were less than 0.99.Conclusions and relevanceThese findings suggest that in the UK, RARP has an ICER lower than the willingness-to-pay threshold and thus is likely a cost-effective surgical treatment option for patients with localized prostate cancer compared with ORP and LRP. The results were mainly driven by the lower risk of BCR for RARP. These findings may differ in other health care settings where different thresholds and costs may apply.

Project description:BackgroundRobotic radical prostatectomy (RARP) is a first-line curative treatment option for localized prostate cancer. Postoperative erectile dysfunction and urinary incontinence are common associated adverse side effects that can negatively impact patients' quality of life. Preserving the lateral neurovascular bundles (NS) during RARP improves functional outcomes. However, selecting men for NS may be difficult when there is concern about incurring in positive surgical margin (PSM) which in turn risks adverse oncological outcomes. The NeuroSAFE technique (intra-operative frozen section examination of the neurovascular structure adjacent prostate margin) can provide real-time pathological consult to promote optimal NS whilst avoiding PSM.MethodsNeuroSAFE PROOF is a single-blinded, multi-centre, randomised controlled trial (RCT) in which men are randomly allocated 1:1 to either NeuroSAFE RARP or standard RARP. Men electing for RARP as primary treatment, who are continent and have good baseline erectile function (EF), defined by International Index of Erectile Function (IIEF-5) score > 21, are eligible. NS in the intervention arm is guided by the NeuroSAFE technique. NS in the standard arm is based on standard of care, i.e. a pre-operative image-based planning meeting, patient-specific clinical information, and digital rectal examination. The primary outcome is assessment of EF at 12 months. The primary endpoint is the proportion of men who achieve IIEF-5 score ≥ 21. A sample size of 404 was calculated to give a power of 90% to detect a difference of 14% between groups based on a feasibility study. Oncological outcomes are continuously monitored by an independent Data Monitoring Committee. Key secondary outcomes include urinary continence at 3 months assessed by the international consultation on incontinence questionnaire, rate of biochemical recurrence, EF recovery at 24 months, and difference in quality of life.DiscussionNeuroSAFE PROOF is the first RCT of intra-operative frozen section during radical prostatectomy in the world. It is properly powered to evaluate a difference in the recovery of EF for men undergoing RARP assessed by patient-reported outcome measures. It will provide evidence to guide the use of the NeuroSAFE technique around the world.Trial registrationNCT03317990 (23 October 2017). Regional Ethics Committee; reference 17/LO/1978.

Project description:IntroductionRobot-assisted laparoscopic prostatectomy (RALP) offers potential cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP. There is reluctance, however, to perform NS RALP when there are concerns that the cancer extends beyond the capsule of the prostate into the NVB, as NS RALP in this instance increases the risk of a positive surgical margin (PSM). The NeuroSAFE technique involves intraoperative fresh-frozen section analysis of the posterolateral aspect of the prostate margin to assess whether cancer extends beyond the capsule. There is evidence from large observational studies that functional outcomes can be improved and PSM rates reduced when the NeuroSAFE technique is used during RALP. To date, however, there has been no randomised controlled trial (RCT) to substantiate this finding. The NeuroSAFE PROOF feasibility study is designed to assess whether it is feasible to randomise men to NeuroSAFE RALP versus a control arm of 'standard of practice' RALP.MethodsNeuroSAFE PROOF feasibility study will be a multicentre, single-blinded RCT with patients randomised 1:1 to either NeuroSAFE RALP (intervention) or standard RALP (control). Treatment allocation will occur after trial entry and consent. The primary outcome will be assessed as the successful accrual of 50 men at three sites over 15 months. Secondary outcomes will be used to aid subsequent power calculations for the definitive full-scale RCT and will include rates of NS; PSM; biochemical recurrence; adjuvant treatments; and patient-reported functional outcomes on potency, continence and quality of life.Ethics and disseminationNeuroSAFE PROOF has ethical approval (Regional Ethics Committee reference 17/LO/1978). NeuroSAFE PROOF is supported by National Institute for Healthcare Research Research for Patient Benefit funding (NIHR reference PB-PG-1216-20013). Findings will be made available through peer-reviewed publications.Trial registration numberNCT03317990.

Dataset Information

Retzius-sparing versus standard robotic-assisted laparoscopic prostatectomy for the treatment of clinically localized prostate cancer.

Publications

Retzius-sparing versus standard robotic-assisted laparoscopic prostatectomy for the treatment of clinically localized prostate cancer.

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