Abstract: We included two unique studies with 446 randomised participants with clinically localised prostate cancer. The mean age, prostate volume, and prostate-specific antigen (PSA) of the participants were 61.3 years, 49.78 mL, and 7.09 ng/mL, respectively. Primary outcomes  We found no study that addressed the outcome of prostate cancer-specific survival. Based on data from one trial, RARP likely results in little to no difference in urinary quality of life (MD -1.30, 95% CI -4.65 to 2.05) and sexual quality of life (MD 3.90, 95% CI -1.84 to 9.64). We rated the quality of evidence as moderate for both quality of life outcomes, downgrading for study limitations. Secondary outcomes  We found no study that addressed the outcomes of biochemical recurrence-free survival or overall survival. Based on one trial, RARP may result in little to no difference in overall surgical complications (RR 0.41, 95% CI 0.16 to 1.04) or serious postoperative complications (RR 0.16, 95% CI 0.02 to 1.32). We rated the quality of evidence as low for both surgical complications, downgrading for study limitations and imprecision. Based on two studies, LRP or RARP may result in a small, possibly unimportant improvement in postoperative pain at one day (MD -1.05, 95% CI -1.42 to -0.68 ) and up to one week (MD -0.78, 95% CI -1.40 to -0.17). We rated the quality of evidence for both time-points as low, downgrading for study limitations and imprecision. Based on one study, RARP likely results in little to no difference in postoperative pain at 12 weeks (MD 0.01, 95% CI -0.32 to 0.34). We rated the quality of evidence as moderate, downgrading for study limitations. Based on one study, RARP likely reduces the length of hospital stay (MD -1.72, 95% CI -2.19 to -1.25). We rated the quality of evidence as moderate, downgrading for study limitations. Based on two study, LRP or RARP may reduce the frequency of blood transfusions (RR 0.24, 95% CI 0.12 to 0.46). Assuming a baseline risk for a blood transfusion to be 8.9%, LRP or RARP would result in 68 fewer blood transfusions per 1000 men (95% CI 78 fewer to 48 fewer). We rated the quality of evidence as low, downgrading for study limitations and indirectness. We were unable to perform any of the prespecified secondary analyses based on the available evidence. All available outcome data were short-term and we were unable to account for surgeon volume or experience. There is no high-quality evidence to inform the comparative effectiveness of LRP or RARP compared to ORP for oncological outcomes. Urinary and sexual quality of life-related outcomes appear similar. Overall and serious postoperative complication rates appear similar. The difference in postoperative pain may be minimal. Men undergoing LRP or RARP may have a shorter hospital stay and receive fewer blood transfusions. All available outcome data were short-term, and this study was unable to account for surgeon volume or experience.

Plain-language summary: This review identified two randomised controlled trials of 446 men with prostate cancer, with an average age of approximately 60 years, that compared LRP or RARP to ORP. We found no evidence as to how LRP or RARP compared to ORP in terms of reducing the risk of dying from prostate cancer, preventing the cancer from coming back or dying of any cause. Mens' quality of life was likely similar related to their urinary and sexual function. There appears to be no differences in postoperative surgical complications. LRP or RARP may have a small possibly unimportant effect on postoperative pain at one day and up to one week. However, no difference between RARP and ORP was found at 12 weeks postoperatively. Men having LRP or RARP likely have a shorter hospital stay and may need fewer blood transfusions. We found no trial evidence for any cancer outcome. The evidence for quality of life were moderate; that for overall and serious surgical complications were low quality. Postoperative pain were low (up to one week) and moderate (at 12 weeks) quality of evidence. The quality of evidence for hospital stay and blood transfusions were moderate and low, respectively. Collectively, the most outcomes were low to moderate quality of evidence. This means that our estimates are likely to be close to the truth but that there is a possibility that they may be different.