The PIVOT Study: No "Game-Changer”
Flawed Study Results in Misleading Advice for Men Considering Surgery
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.
that 15 percent couldn't walk, and
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.
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.
This is old news.
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.
| The Bottom Line
The PIVOT study provides no useful information for an otherwise healthy man in his forties, fifties, or early sixties who is contemplating whether he should undergo surgical therapy.
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