Robotic Surgical System for Radical Prostatectomy: A Health Technology Assessment

Abstract

Background: Prostate cancer is the second most common type of cancer in Canadian men. Radical prostatectomy is one of the treatment options available, and involves removing the prostate gland and surrounding tissues. In recent years, surgeons have begun to use robot-assisted radical prostatectomy more frequently. We aimed to determine the clinical benefits and harms of the robotic surgical system for radical prostatectomy (robot-assisted radical prostatectomy) compared with the open and laparoscopic surgical methods. We also assessed the cost-effectiveness of robot-assisted versus open radical prostatectomy in patients with clinically localized prostate cancer in Ontario.

Methods: We performed a literature search and included prospective comparative studies that examined robot-assisted versus open or laparoscopic radical prostatectomy for prostate cancer. The outcomes of interest were perioperative, functional, and oncological. The quality of the body of evidence was examined according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also conducted a cost-utility analysis with a 1-year time horizon. The potential long-term benefits of robot-assisted radical prostatectomy for functional and oncological outcomes were also evaluated in a 10-year Markov model in scenario analyses. In addition, we conducted a budget impact analysis to estimate the additional costs to the provincial budget if the adoption of robot-assisted radical prostatectomy were to increase in the next 5 years. A needs assessment determined that the published literature on patient perspectives was relatively well developed, and that direct patient engagement would add relatively little new information.

Results: Compared with the open approach, we found robot-assisted radical prostatectomy reduced length of stay and blood loss (moderate quality evidence) but had no difference or inconclusive results for functional and oncological outcomes (low to moderate quality evidence). Compared with laparoscopic radical prostatectomy, robot-assisted radical prostatectomy had no difference in perioperative, functional, and oncological outcomes (low to moderate quality evidence). Compared with open radical prostatectomy, our best estimates suggested that robot-assisted prostatectomy was associated with higher costs ($6,234) and a small gain in quality-adjusted life-years (QALYs) (0.0012). The best estimate of the incremental cost-effectiveness ratio (ICER) was $5.2 million per QALY gained. However, if robot-assisted radical prostatectomy were assumed to have substantially better long-term functional and oncological outcomes, the ICER might be as low as $83,921 per QALY gained. We estimated the annual budget impact to be $0.8 million to $3.4 million over the next 5 years.

Conclusions: There is no high-quality evidence that robot-assisted radical prostatectomy improves functional and oncological outcomes compared with open and laparoscopic approaches. However, compared with open radical prostatectomy, the costs of using the robotic system are relatively large while the health benefits are relatively small.

Figure 1:. PRISMA Flow Diagram for the Clinical Evidence Review

Figure 2:. Transfusion Rates for Robot-Assisted Versus Open Radical Prostatectomy

Figure 3:. Urinary Continence Outcomes for Robot-Assisted Versus Open Radical Prostatectomy at 12 Months

Figure 4:. Erectile Function Outcomes for Robot-Assisted Versus Open Radical Prostatectomy at 12 Months

Figure 5:. Overall Positive Surgical Margin Rates for Robot-Assisted Versus Open Radical Prostatectomy

Figure 6:. Positive Surgical Margin Rates in Cancer Stage pT2 for Robot-Assisted Versus Open Radical Prostatectomy

Figure 7:. Positive Surgical Margin Rates in Cancer Stage pT3 for Robot-Assisted Versus Open Radical Prostatectomy

Figure 8:. Mean Operative Time for Robot-Assisted Versus Laparoscopic Radical Prostatectomy

Figure 9:. Length of Hospital Stay for Robot-Assisted Versus Laparoscopic Radical Prostatectomy

Figure 10:. Transfusion Rates for Robot-Assisted Versus Laparoscopic Radical Prostatectomy

Figure 11:. Indwelling Catheterization Duration for Robot-Assisted Versus Laparoscopic Radical Prostatectomy

Figure 12:. Overall Positive Surgical Margin Rates for Robot-Assisted Versus Laparoscopic Radical Prostatectomy

Figure 13:. Positive Surgical Margin Rates in pT2 Cancer for Robot-Assisted Versus Laparoscopic Radical Prostatectomy

Figure 14:. Positive Surgical Margin Rates in pT3 Cancer for Robot-Assisted Versus Laparoscopic Radical Prostatectomy

Figure 15:. PRISMA Flow Diagram for the Economic Evidence Review

Figure 16:. Markov Decision-Analytic Model for Scenario Analyses

Figure 17:. Process of Estimating Utility Values and QALYs

Figure 18:. Tornado Diagram of One-Way Sensitivity Analysis, Robot-Assisted Versus Open Radical Prostatectomy^a

Figure 19:. Incremental Cost and QALYs of Robot-Assisted Versus Open Radical Prostatectomy^a