The Prostate Cancer Intervention Versus Observation Trial (PIVOT) found that men with localized prostate cancer survived just as long regardless of whether they underwent prostate-removal surgery.
The study enrolled 731 men with localized prostate cancer diagnosed through prostate-specific antigen (PSA) blood tests and biopsies.1 Approximately one-half of the men were randomly assigned to undergo radical prostatectomies whereas the others were assigned to an observation group. The latter received palliative care or chemotherapy if their cancer progressed. After 12 years of follow-up, researchers found no real difference between the groups in terms of the number of men who died of prostate cancer or its treatment.
Participants were classified as having low-risk, intermediate-risk, or high-risk prostate cancer based on their PSA levels and Gleason scores. They found that men in the low-risk category were least likely to benefit from surgery, and the results support the recommendation that men with localized prostate cancer, and particularly those with low-risk disease, benefit from observation versus surgery. Approximately 21.4% of men in the surgery group developed a complication within 30 days of surgery, including 1 death. Infection was the most common complication, whereas urinary incontinence and impotence were much more common 2 years after surgery in the surgery group compared with the observation group.
In an accompanying editorial, Ian Thompson, MD, of the University of Texas Health Science Center in San Antonio, and Catherine Tangen, DrPH, of the Fred Hutchinson Cancer Research Center in Seattle, Washington, pointed out that the trial's size may have impacted its results. They noted that PIVOT originally was designed to enroll 2000 patients, but because of difficulty in recruiting patients, the trial was changed. Ultimately, they concluded that there were too few patients to definitively demonstrate that surgery could reduce mortality.
Meanwhile, the American Society of Clinical Oncology published recommendations by an expert committee that advised against PSA screening for prostate cancer in men with a life expectancy of fewer than 10 years and recommended that physicians discuss the potential benefits and risks of PSA testing with men who have a life expectancy of 10 years or more.2 These recommendations are similar to those of the American Cancer Society, which suggests that this discussion should occur starting at age 50 years for men who are at average risk of developing prostate cancer and at age 45 years for men who are at higher risk of the disease.