Open, robotic prostatectomy produce similar early functional outcomes

Robotic-assisted laparoscopic prostatectomy and open radical prostatectomy demonstrated similar 3-month postoperative outcomes for patients with localized prostate cancer, according to results of a randomized controlled phase 3 study.

Robot-assisted laparoscopic prostatectomy has been used since 2000; however, no head-to-head trial has yet compared the procedure with open radical prostatectomy.

“Surgery has long been the dominant approach for the treatment of localized prostate cancer, with many clinicians now recommending the robotic method to patients,” Robert A. Gardiner AM, MBBS, MD, FRCS, FRACS, professor at University of Queensland School of Medicine and consultant urologist at Royal Brisbane & Women’s Hospital in Australia, said in a press release. “Many clinicians claim the benefits of robotic technology lead to improved quality of life and oncological outcomes.”

Gardiner and colleagues evaluated data from 326 men (mean age, 60.01 ± 6.24 years), with newly diagnosed localized prostate cancer, who chose surgery as their preferred treatment platform. All men were aged between 35 years and 70 years and had a life expectancy of at least 10 years.

Researchers randomly assigned men to undergo radical retropubic prostatectomy or robot-assisted laparoscopic prostatectomy (n = 163 for each). Eighteen patients withdrew consent prior to surgery, leaving 151 active patients in the open prostatectomy arm and 157 patients in the robot-assisted prostatectomy arm.

Primary outcome measures included urinary and sexual function at 6 weeks, 12 weeks and 24 weeks after surgery, as well as oncological outcomes — including positive surgical margin status and biochemical or imaging evidence of progression — at 24 months.

To assess these domains, researchers used questionnaires that utilized the Expanded Prostate Cancer Index Composite, International Index of Erectile Function Questionnaire and International Prostate Symptom Score. In total, 121 men assigned open prostatectomy and 131 men assigned robot-assisted prostatectomy completed 12-week questionnaires.

Both groups had similar urologic outcome scores at 6 weeks (radical vs. robot assisted, 74.5 vs. 71.1) and 12 weeks (83.8 vs. 82.5) after surgery.

Sexual functioning scores also did not significantly differ at 6 weeks (30.7 vs. 32.7) or 12 weeks (35 vs. 38.9).

The researchers observed few difference in the use of pads to control urinary incontinence or in the quality of erections after surgery.

Researchers conducted equivalency analyses for surgical margins between the two groups with a two-sided 90% CI of the difference between the proportion of positive margins. Results showed a 0.052 (90% CI, –0.01 to 0.11) point estimate difference, which was above the specified difference of 0.1 to establish equivalence.

However, a superiority test that compared the positive margin rate in each arm did not show a statistically significant difference (radical vs. robot assisted, 10% vs. 15%).

Patients assigned robot-assisted surgery reported less pain during normal activities and lower amounts of worst-reported pain in the very early postoperative period (24 hours and 1 week following surgery); however, no significant differences were evident at 6 weeks or 12 weeks.

A similar proportion of patients in each arm who worked full- or part-time (radical, n = 66; robot assisted, n = 63) returned to work at 12 weeks (mean, 42.71 for both).

Men assigned open prostatectomy had longer operating-room time and surgery time (P < .0001 for both), although the amount of time spent in recovery did not significantly differ.

Open prostatectomy also resulted in longer average time spent in the hospital after surgery and greater estimated total blood loss (P < .0001 for both).

Fourteen men assigned open prostatectomy experienced postoperative complications, compared with four men assigned robot-assisted laparoscopic surgery. Intraoperative adverse events occurred in 12 men assigned open prostatectomy and three men assigned robot-assisted prostatectomy.

The researchers acknowledged the use of one treatment center and two surgeons as a potential study limitation.

“Patients are now being followed-up for a total of 2 years in order to fully assess the longer-term outcomes, including on cancer survival,” Gardiner said. “In the meantime, patients should choose an experienced surgeon they trust and with whom they have a rapport, rather than basing their decision on a specific surgical approach.”

Clinicians and researchers should not interpret the lack of superiority shown in this trial for robot-assisted laparoscopic surgery as a failure, Erik Mayer, MBBS (Hons), BSc (Hons), MRCS, PhD, FRCS (Urol), and Ara Darzi, Baron Darzi of Denham OM, KBE, PC, FRS, FMedSci, FRCS, FRCSE, FACS, HonFREng, both of the department of surgery and cancer at Imperial College, London, wrote in an accompanying editorial.

“Trials that show equivalence for an innovation are sometimes interpreted as supporting a return to existing practice, including rediverting the training of a generation of surgeons who might have followed the innovation’s evolution,” Mayer and Darzi wrote. “Equivalence and noninferiority should also be seen as positive, showing the innovation has preserved the intended and well-established purpose of surgical intervention, such as good oncological outcomes balanced against acceptable functional side effects. It is these advances in applied technology, reducing the trauma of access and the invasiveness of surgery, that also provide the platform on which to develop adjunct technological innovations towards further improving the quality and safety of surgery.” – by Cameron Kelsall

Disclosure: The researchers, Mayer and Darzi report no relevant financial disclosures.