Like the PLCO study, the PIVOT study is long; it has a three-year enrollment period, and a twelve-year follow-up; 2,000 men will be able to participate. Men up to age 75 are eligible—but these older men, like the rest of the men in the study, must be healthy enough to be considered fit for surgery. Only men with prostate cancer who are considered candidates for surgery may take part in the study; they will be assigned to one of two groups—either they’ll undergo a radical prostatectomy, or they will be followed closely with watchful waiting and treated as needed for specific symptoms or metastases. Many cancer centers and Veterans Administration hospitals throughout the country are participating in this study.
What’s the measure of success here? It’s what you might call the ultimate endpoint—death or survival. “Really, that’s what the patient cares about,” says the internist. “Will my disease be cured? Is my life better without the surgery? We don’t know the answer to either of those questions. Those in favor of radical prostatectomy say, ‘How can doctors dare not treat? They’re killing people with watchful waiting!’ And the watchful waiting people say that surgery doesn’t prolong survival. These are two groups of intelligent, caring people, and there is information to support either of these two views.”
Men in the study will be examined at least every three months the first year and every six months afterward, and periodically they will answer questionnaires about their quality of life. Their doctors will check for any evidence that prostate cancer has progressed, and they will document any changes in the patients’ condition. If the patient dies, for any reason, all of this information will go to an independent review committee, which will study all the accumulated data and determine whether the man’s death was definitely, probably, possibly, or definitely not due to prostate cancer.
The PIVOT study is interesting for several reasons; despite the age limit of its patients—it’s hard to know how many 75-year-old men will be around for the study’s conclusion—the selection criteria seem fairly strict. Men who obviously are not good candidates for surgery, the study’s directors say, will not be included. Also, because of its size, the study promises highly specific results.
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Tags: Erectile Dysfunction, Men’s Health