Approved in Europe, skeptics in United States
The FDA's European counterpart has already approved the test, he says. Catalona estimates that 18 percent of the 50 million American men who annually have their PSA levels tested fall into the diagnostic gray zone, so if the test is approved here, some 9 million men might be eligible to take it.
Not everyone shares Catalona's enthusiasm, however.
James L. Mohler, M.D., a urologist at the Roswell Park Cancer Institute and chair of the National Comprehensive Cancer Network's prostate cancer treatment guideline panel, says Catalona "basically improved the ability of the PSA to separate the benign from the cancer a little bit."
The study itself had some shortcomings, Mohler says.
Although Catalona "showed some differences that were interesting," the study should be repeated with more men who are studied over a longer period of time to see whether the Pro-PSA test really is more accurate.
Oliver Sartor, M.D., a urology professor and medical director of the Tulane University Cancer Center, agrees that the test is "better" at detecting who has cancer. But he cautions it's not ready for prime time, adding it may not help patients avoid biopsies. "Furthermore, the test clearly is not good enough to decide whether or not a cancer needs to be treated or not," he says.
"It moves us forward a little bit, but this isn't the answer to prostate cancer that we've all been looking for."
Michael Haederle is a freelance writer whose work has appeared in People, the New York Times and the Los Angeles Times.
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