By Mark Scholz, MD
For men with prostate cancer on active surveillance or (“watchful waiting,” as it is often known), new and compelling data from a large study called the “PIVOT Trial” was presented at the annual meeting of the American Society of Urology in 2011. In this trial, which started in 1994, 731 men volunteered to get either watchful waiting or immediate surgery based on a coin flip. The goal of the trial was to determine if immediate surgery prolongs life compared to watchful waiting.
The men in the study had a median PSA of 7.8. One strength of the study was the fact that 75% of the men were diagnosed after biopsy for a rising PSA (as opposed to feeling a lump on the prostate). This means that these study results can be more easily compared to the situation men face in this modern era. The weakness of previously published watchful waiting studies was that they were done on men with more advanced disease, cancer that was diagnosed by feeling an abnormality on the prostate gland during a digital rectal exam (DRE)—so called palpable disease, a situation that is far less common these days.
The breakdown of the risk categories of the men participating in the study was similar to what is commonly reported in men with newly-diagnosed prostate cancer in the modern era:
- 43% Low-Risk
- 36% Intermediate–Risk
- 20% High-Risk
The surprising finding, after 12 years, was that there was no difference in survival between surgery and watchful waiting in the Low-Risk or in the Intermediate-Risk group. On the other hand, men who were in the High-Risk category did benefit with improved 12-year survival when treated with immediate surgery compared to the men with High-Risk disease who did watchful waiting.
The results of the PIVOT Trial are very important because up till now only men with Low-Risk prostate cancer were thought to be safe candidates to do watchful waiting.
We eagerly await the final publication of all the data from the PIVOT Trial since expanding the recommendation for watchful waiting to men with Intermediate-Riskdisease would essentially double the number of men in the United States who would be eligible for monitoring. Additionally, this new discovery that men with Intermediate-Risk prostate can be safely monitored provides even stronger assurance to men with Low-Risk disease who have been experiencing trepidation about forgoing immediate treatment.
A board-certified medical oncologist, Mark C. Scholz, MD, serves as medical director of Prostate Oncology Specialists Inc. in Marina del Rey, CA, a medical practice exclusively focused on prostate cancer. He is also the executive director of the Prostate Cancer Research Institute. He received his medical degree from Creighton University in Omaha, NE. Dr. Scholz completed his Internal Medicine internship and Medical Oncology fellowship at University of Southern California Medical Center. He is the co-author of the book Invasion of the Prostate Snatchers: No More Unnecessary Biopsies, Radical Treatment or Loss of Potency. He is a strong advocate for patient empowerment.