April 28, 2010 ( Barcelona, Spain) — Men with seemingly low-risk prostate cancer who are considered candidates for an active surveillance strategy might want to consider robotic-assisted laparoscopic prostatectomy (RALP) instead, a team from Mount Sinai Medical Center in New York City reported here at the European Association of Urology 25th Annual Congress.
Active surveillance, otherwise known as watchful waiting, has been enjoying a surge in popularity as a management option for men with low-risk localized prostate cancer.
The new results are drawn from a trial that evaluated the final histopathologic and functional outcomes of a large cohort of men who qualified for active surveillance under conventional active surveillance criteria, but who opted instead for RALP.
The researchers found a 44% rate of upgrading of cancers. However, there was a low rate of upstaging, and a nerve-sparing procedure was performed in most patients with excellent potency and continence outcomes.
"The findings are extremely important," David Samadi, MD, chief of the Division of Robotics and Minimally Invasive Surgery, told Medscape Urology. "First, the 44% upgrading rate in men whom we thought had slow growing disease represents men who never should have been placed on active surveillance in the first place," he said. "Second, we demonstrated that we can eliminate the risk of missing an aggressive cancer by successfully treating these men with minimal compromise to their quality of life."
Recent studies have questioned the use of radical therapy for all patients with prostate cancer, especially those with low-risk disease, in favor of active surveillance, Dr. Samadi observed. At the same time, improvements in surgical and radiotherapy techniques and perioperative management have decreased the morbidity of prostate cancer treatments.
Although active surveillance has been shown to be a valid treatment option for patients with low-risk disease, clinically low-risk prostate cancer does not necessarily translate into indolent or insignificant disease on final pathology, he added. Given the difficulties of accurate preoperative staging and grading of prostate cancer, upgrading and upstaging are extremely common at the time of prostatectomy.
When discussing treatment options for men who are candidates for active surveillance, it is important to be able to provide solid data on outcomes, both histopathologic and functional, following prostatectomy. This study was designed to provide such data to patients deciding between RALP and active surveillance.
Dr. Samadi presented data on 368 men deemed candidates for active surveillance who were drawn from a "prospectively maintained" database of 1249 RALPs.
Men who were categorized as eligible for active surveillance had a prostate-specific antigen (PSA) below 10 ng/mL, a clinical stage of T2A or below, and a biopsy Gleason score of 6 or less in 1 or 2 cores, with less than 50% tumor volume in a single core.
The study found that, on final histopathology, 147 active surveillance candidates (40%) were upgraded from a Gleason 6 biopsy score to 3 + 4 = 7. Fifteen (4.1%) patients were upgraded to 4 + 3 = 7, and 1 patient was upgraded to Gleason 8 or higher.
Seventeen patients (4.6%) were upstaged to pT3 or pT4 disease, and 12 of these were also upgraded.
Bilateral nerve-sparing was performed in 97% of patients.
Follow-up of 221 patients at 12 months showed that 88% of men had recovered potency (meaning they were potent preoperatively and had a Sexual Health Inventory for Men score of 16), and 95% were continent (meaning they needed 0 or 1 security pad per day).
Biochemical recurrence, defined as a PSA of 0.2 ng/mL at least 6 weeks after prostatectomy, occurred in 1.6% of patients at a median follow-up of 13.9 months.
As for which men with prostate cancer should choose active surveillance over RALP, Dr. Samadi said: "I think that active surveillance is ideal for older men and those whose PSA doubling time and velocity are slow."
"This study is interesting and somewhat surprising," Carl A. Olsson, MD, John K. Lattimer Professor of Urology (emeritus) at Columbia University College of Physicians and Surgeons in New York City, told Medscape Urology. "What surprised me is the 44% rate of upgrading, which is substantially higher than the 10% to 20% rate reported in the studies I am familiar with."
Dr. Olsson, who is also chief medical officer at Integrated Medical Professionals, PLLC, in Melville, New York, noted that "it would be interesting to know who did the actual pathology reporting."
He added that if the data are true, "they would put a damper on any policy of active surveillance in patients presumed to be at low risk preoperatively."
Dr. Samadi and Dr. Olsson have disclosed no relevant financial relationships.
European Association of Urology (EAU) 25th Annual Congress: Abstract 578. Presented April 18, 2010.