Harvard Men's Health Watch

FDA approves new PSA test

The FDA has approved a new kind of PSA test for determining prostate cancer risk. The company that developed the test, Beckman Coulter, Inc., claims that it can help physicians to tell the difference between prostate cancer and benign prostate conditions.

The Prostate Health Index (PHI) test is approved for use in men 50 years and older with a total PSA between 4.0 and 10 nanograms per milliliter (ng/ml) and whose physical exam does not find signs of cancer. Making a diagnosis in this PSA range requires a biopsy, but it would find cancer only 25% of the time. The PHI test is intended to help doctors determine which men with a PSA between 4.0 and 10 are most likely to have prostate cancer, potentially reducing unnecessary biopsies.

But doctors must take care not to allow use of the PHI test to worsen the existing overdiagnosis and overtreatment of low-risk cancers, says Dr. Marc Garnick, an expert in prostate cancer at Harvard Medical School. "This is really a slippery slope," Dr. Garnick says. "Unless the studies showed that more important cancers were identified, and treated, compared to standard testing, and that such treatment led to improved outcomes, its use should be met with great caution."

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