At 24 months’ follow-up, the only phase 3 randomized clinical trial to directly compare functional and oncologic outcomes between robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy shows no evidence for a clear advantage of one approach over the other, say researchers.
The international study was led by Robert “Frank” Gardiner, MD, from the University of Queensland Center for Clinical Research at Royal Brisbane and Women’s Hospital, Australia.
The new results at 24 months’ follow-up were published online July 12 in the Lancet Oncology.
As previously reported by Medscape Medical News, the trial’s 3-month follow-up results, published in 2016, showed no significant differences in functional and oncologic outcomes between the two approaches.
The current study shows that functional and sexual outcomes for both approaches have remained comparable at 6, 12, and 24 months’ follow-up.
However, the oncologic outcomes “require ongoing follow-up and further investigation,” the authors say.
The study also showed that 1 of 5 patients continued to experience high levels of psychological distress, regardless of surgical approach.
“Robot-assisted laparoscopic prostatectomy has been widely adopted as the preferred surgical technique for radical prostatectomy without previous validation of improved outcomes,” Franklin and colleagues write. “Our study showed that this technique can obtain equivalent functional outcomes to open surgery, with a decreased risk of biochemical recurrence during 24-month follow-up.”
“[A]lthough our results might have implications for long-term patient outcomes, further validation is needed,” they comment. “Clinicians and patients should view the benefits of a robotic approach as being largely related to its minimally invasive nature.”
In an email, Gardiner emphasized that the oncologic outcomes “need to be taken with circumspection. Two years is but a short time in terms of prostate cancer follow-up.”
Gardiner also pointed out that “relying on PSA [prostate-specific antigen] at 24 months without fully taking into account patients who had undergone treatments known to lower PSA values could be misleading ultimately in terms of cancer outcomes.”
The researchers “will continue to monitor these patient groups to ascertain if there is a better oncological outcome for one procedure compared with the other,” Gardiner told Medscape Medical News. “In the absence of evidence for a clear advantage for one approach over the other at 24 months, the need to embrace robotic prostatectomies when cost is a critical issue, for example in Third World countries, should be questioned,” he added.