The first direct comparison between robot-assisted laparoscopic prostatectomy and open surgery (radical retropubic prostatectomy) has ended in a tie.
Early results from an international, randomized, phase 3 trial comparing the two approaches show no significant differences in health-related and quality-of-life outcomes at 12 weeks.
The results were published online July 26 in the Lancet.
"Our randomized trial, the first of its kind, found no statistical difference in quality of life outcomes between the two groups at 12 weeks' follow-up," commented senior author Robert "Frank" Gardiner, MD, from the University of Queensland Center for Clinical Research, Royal Brisbane and Women's Hospital, Australia. Their analysis included assessment of standard oncologic and quality- of-life parameters, such as positive surgical margins and return of urinary, bowel, and sexual function, he added.
Patients will be followed for a total of 2 years to fully assess the longer-term outcomes, including cancer survival, he noted.
Until results of this longer follow-up are published, "patients should choose an experienced surgeon with whom they relate well rather than a specific surgical approach," Dr Gardiner told Medscape Medical News.
It is the longer-term outcomes yet to be reported that are important, says an expert not involved in the study.
The full implications for clinical practice will be revealed when longer-term functional and oncologic outcomes are available, Ara Darzi, MD, Department of Surgery and Cancer, Imperial College London, United Kingdom, told Medscape Medical News. "As it stands, the study is not powered sufficiently to provide meaningful oncological efficacy data nor to change clinical practice."
Dr Darzi coauthored an accompanying editorial with Erik Mayer, MD, also from Imperial College London.
This study is "an important milestone in the assessment of robotic innovation," they comment.
"The researchers must be congratulated on conducting a complex and successfully randomized control trial on a technological platform in surgery," Dr Darzi told Medscape Medical News. "That is a considerable and novel achievement."
However, the editorialists note that recruitment into the trial was stopped (at 326 patients) after 4 years because there were no differences in key functional outcomes. Ultimately, they say, this could curtail the group's ability "to generate meaningful data for their chosen oncological outcomes — namely, biochemical recurrence and adjuvant treatment."
Had Anticipated Robot to Be Better
"Many clinicians claim the benefits of robotic technology lead to improved quality of life and oncological outcomes," Dr Gardiner commented in a statement.
He told Medscape Medical News that the investigators had anticipated, on the basis of feedback from patients and reports in the medical literature, that robotic prostatectomy would come out ahead, at least in the short term. "We expected improved short-term (6 weeks and 12 weeks) quality-of-life outcomes for robotic prostatectomy in terms of urinary, sexual and bowel function, health-related quality of life, pain, and time to return to usual activities," he said.
But the early results showed no difference between the two techniques.
For the trial, 326 men aged 35 to 70 years with newly diagnosed clinically localized prostate cancer were recruited from the Royal Brisbane and Women's Hospital between August 23, 2010, and November 25, 2014. All had opted for surgical treatment.
Participants were randomly assigned in a 1-to-1 ratio to receive either of the two techniques; 157 patients underwent robot-assisted laparoscopic prostatectomy, and 151 underwent radical retropubic prostatectomy.
Data analysis was completed by investigators masked to each patient's condition, and biopsy and radical prostatectomy specimens were reviewed by a masked central pathologist.
Results showed that there was no significant difference in urinary function scores between the radical retropubic prostatectomy group and the robot-assisted laparoscopic prostatectomy group at 6 weeks post surgery (74.50 vs 71·10; P = .09) and 12 weeks post surgery (83.80 vs 82.50; P = .48).
Similarly, sexual function scores did not differ significantly between the radical retropubic prostatectomy group and the robot-assisted laparoscopic prostatectomy group at 6 weeks (30.70 vs 32.70; P = .45) or 12 weeks (35.00 vs 38.90; P = .18).
The rates of positive surgical margins were relatively low compared with rates reported previously in large series: 15% in the robot-assisted laparoscopic prostatectomy group and 10% in the open-surgery group. Positive surgical margins are associated with an increased rate of biochemical relapse and a higher likelihood of the need for subsequent treatment, the researchers note.
In keeping with minimally invasive surgery, patients who underwent robot-assisted laparoscopic prostatectomy experienced less blood loss and a shorter hospital stay than those in the open- surgery group. No patient in either group required a blood transfusion during the procedure.
This study was funded by Cancer Council Queensland. The authors and the editorialists have disclosed no relevant financial relationships.
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Cite this: Robot vs Human Prostatectomy: It's a Tie, at Least So Far - Medscape - Jul 27, 2016.