2 The procedure

2.1 Indications

2.1.1 Laparoscopic radical prostatectomy is indicated for localised prostate cancer with no evidence of spread beyond the prostate or of distant metastases.

2.1.2 Alternative treatment options include active monitoring (sometimes called watchful waiting), open radical prostatectomy, external beam radiotherapy, low-dose brachytherapy, combined external beam radiotherapy with high-dose brachytherapy, high-intensity focused ultrasound therapy, and cryotherapy.

2.2 Outline of the procedure

2.2.1 A laparoscope and trocars are inserted through small incisions in the abdominal wall. The approach can be either transperitoneal or extraperitoneal. The prostate, adjacent tissue and lymph nodes are dissected and removed, and the urethra, which is cut during the procedure, is reconnected. Lymph nodes can be removed during the procedure for histological examination before removing the prostate. Robotically assisted laparoscopic prostatectomy is a development of this procedure but it is not yet clear whether there is any advantage over conventional laparoscopy.

2.3 Efficacy

2.3.1 In a systematic review of non-randomised controlled studies, biochemically assessed recurrence-free survival ranged between 84% (36 months' follow-up) and 99% (30 months) following transperitoneal laparoscopic radical prostatectomy, between 81% (10 months) and 91% (12 months) following extraperitoneal laparoscopic radical prostatectomy, and between 92% (8 months) and 95% (3 months) following robotically assisted laparoscopic radical prostatectomy. None of these outcomes was significantly different from those observed in men undergoing open radical prostatectomy.

2.3.2 In a systematic review of non-randomised controlled trials, 8 of 11 studies comparing either the transperitoneal or extraperitoneal laparoscopic approach with open radical prostatectomy reported no significant difference in rates of tumour-positive resection margins between the two procedures. The other three studies in the review reported significant differences: 50% (transperitoneal) versus 29% (open) (p = 0.03), 14% (transperitoneal) versus 26% (open) (p = 0.02) and 26% (extraperitoneal) versus 40% (open) (p = 0.0001). Pooled data from six case series and two databases indicated a tumour-positive resection margin in 20% of 1439 men treated with laparoscopic radical prostatectomy (any approach) and 24% of 22,164 men treated with open radical prostatectomy. For more details, refer to the 'Sources of evidence' section.

2.3.3 The Specialist Advisers stated that the benefits of laparoscopic radical prostatectomy may include low positive surgical margin rates, and good biochemically assessed recurrence-free survival.

2.4 Safety

2.4.1 In a systematic review of ten non-randomised controlled studies, five studies reported no significant differences between the different methods of radical prostatectomy in rates of post-operative urinary continence. One study reported a significant difference that favoured laparoscopic surgery, and four did not report whether differences in continence rates were statistically significant.

2.4.2 In a review of pooled data, the mean blood loss was less with laparoscopic radical prostatectomy (505 ml) or robotically assisted laparoscopic prostatectomy (231 ml) than with open surgery (727 ml) (p value not reported).

2.4.3 In the studies that reported on erectile dysfunction as a complication, potency was retained in 53–62% of men who were potent at baseline. Preserved potency rates of 82% were reported in men treated with robotically assisted laparoscopic radical prostatectomy. In a systematic review of non-randomised controlled studies, three studies reported that there was no significant difference in potency rates following laparoscopic or open radical prostatectomy. For more details, refer to the 'Sources of evidence' section.

2.4.4 The Specialist Advisers stated that adverse events reported with laparoscopic radical prostatectomy were similar to those for open procedures. Additional theoretical complications include gas embolus, bowel damage and haemorrhage.