This headline got my immediate attention: “No Benefit with Surgery for Low-Risk Prostate Cancer.” The July 12, 2017 article by MedPage Today Senior Associate Editor Charles Bankhead is based on the most recent follow up findings from the PIVOT randomized trial. They suggest that radical prostatectomy (RP) does not offer men with localized prostate cancer (PCa) a significant survival benefit over active surveillance or other type of observation. For traditional urologists, this might seem close to heresy.
When the PIVOT trial began in 1994, it enrolled 740 men with localized PCa who were randomly assigned either to RP or observation (active surveillance or other forms of monitoring). In 2012, the first PIVOT findings were published. The primary endpoint was overall survival (death from any cause) and the secondary endpoint was prostate cancer-specific survival (death from prostate cancer). Based on the numbers, the authors concluded, “Among men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up.”[i] Thus, RP offered no significant survival benefit from either endpoint.
Now, five years later, 468 out of 731 patients (64%) have died, and the long-term data has been re-analyzed. Median survival with RP is 13 years vs. 12.4 years for observation, but a major difference is patient-reported quality of life. The RP group had far more complaints about things like incontinence, ED, discomfort, limited activities, etc. that men on observation did not go through.
While it may be tempting to ask what’s the point of still pushing robotic RP to patients who would qualify for surveillance, we shouldn’t be too quick to kiss prostatectomy goodbye. After all, the original PIVOT trial was based on criteria for PCa risk level that are no longer acceptable, so some of the enrollees were actually intermediate-to-high risk by today’s standards. The authors of the more recent PIVOT analysis point out that today’s patients under age 65, depending on their clinical factors, may in fact gain a survival advantage from RP. The heart of the matter is correctly identifying such patients.
Our Center provides a complete suite of state-of-the-art diagnostic services for which we are recognized global leaders. These include multiparametric MRI, in-bore MRI targeted biopsies, complex PSA analytics, and genomic testing. We are able to identify, with a very high degree of confidence, which patients are candidates for active surveillance, which men qualify for Focal Laser Ablation (FLA), and which men will be best served by RP. So, before we kiss RP goodbye, let’s make sure it’s the right men who will most benefit from it.
[i] Wilt TJ, Brawer MK, Jones KM, Barry MJ et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012 Jul 19;367(3):203-13. doi: 10.1056/NEJMoa1113162.