The PIVOT Study (Prostate Cancer Intervention Versus Observation Trial), whose results were recently published in the New England Journal of Medicine, began in 1994, early in the PSA era. It was originally designed to be a large study involving 2,000 men who were randomly assigned either to radical prostatectomy or observation. The study itself was severely flawed. For one thing, it was statistically underpowered; the scientists recruited only 731 men, instead of the 2,000. (An editorial that accompanied this article stated that it would require 1,200 patients to fulfill the statistical goal that the study's authors reported.) Also, although the study was designed to include only men with a life expectancy of at least 10 years, at the end of the study half of the participants had died of causes other than cancer, leaving only 171 men in the surgery group and 183 men in the observation group available for analysis at 10 years.The men in this study were so sick
that 15 percent couldn't walk,
within 10 years, half of them had died
of causes other than cancer.
But even worse was the fact that in onehalf of the men, cancer extended outside the prostate, making it difficult to cure. And, although the authors deny it, the follow-up of 10 to 12 years was far too short to be conclusive in making recommendations for men with low risk disease.
All the PIVOT study tells us is
And yet, much of the news media took this story at face value. For example, the New York Times reported: "A new study shows that prostate cancer surgery, which often leaves men impotent or incontinent, does not appear to save the lives of men with early stage disease, who account for most of the cases, and many of these men would do just as well to choose no treatment at all."This study, the newspaper added, was "game-changing.”
If you have already undergone surgery, you might well have wondered, "what have I done?"Unfortunately, many young men with aggressive, curable disease will only remember this sound bite. Is this true? Sadly, no.
Does this Apply to My Cancer, and My Potential to Benefit from Treatment?
The study was carried out at Veterans Administration centers, where the surgery is often performed by inexperienced residents. The average age of the men in this study was 67; only 10 percent of the men were younger than 60. Today, cancer is diagnosed sooner than it was then, and the great majority of men at diagnosis have no symptoms and curable disease. The men in this study were so sick that 15 percent couldn't walk, and within 10 years, half of them had died of causes other than cancer.
The study's authors concluded that "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."This study is a straw man; its authors wanted to mislead readers by suggesting that their findings apply to all men with prostate cancer – when in fact, their results only apply to men who are older or in poor health, and this finding is far from newsworthy. For three decades, we have said that men who have a life expectancy of 10 years or less should not undergo surgery.
The study's authors never conceded that their observations should not be applied to younger men. But an ever-growing volume of evidence shows that in men with low-volume cancer, progression continues for many years. For example, in a study from Sweden of men with very small cancers who were treated with observation alone, death rates from prostate cancer remained very low (15 per 100,000 persons) for the first 15 years – but beyond that point, they skyrocketed (to 44 per 100,000 persons), and nearly all these men eventually died from prostate cancer. The PIVOT authors did not admit this likelihood in their study. Because only 26 men who underwent surgery and 36 men in the observation group were alive at 14 years, this study will never have follow-up long enough to answer this question. With all of these shortcomings, it is surprising that they were able to demonstrate some significant benefits of surgery: There was an overall 60 percent decrease in the risk of metastases and a reduction in prostate cancer deaths in men who had a PSA greater than 10 ng/ml or who were in the high-risk category who underwent surgery.
that for a man who has a life
expectancy of 10 years or less
and who has low-volume disease,
surgery is not an option.
All the PIVOT study tells us is that for a man who has a life expectancy of 10 years or less and who has low-volume disease, surgery is not an ideal option. This is old news, and is far from being a "game-changer."The information in this article is simply not good enough to be of help to an otherwise healthy man in his forties, fifties, or early sixties trying to figure out what he should do.