Archive | May 9th, 2011

Progress in Prostate Cancer Detection with New Pro-PSA Test

For prostate cancer, the only current commercially available screening tests approved by FDA results in a high number of false positive results which leads to unnecessary biopsies, over detection and over treatment of indolent cancer. This is particularly true on the aggressive form of the cancer.

There is a new test that was recently approved for commercial use in Europe.  It is called Pro-PSA.  It measures a more specific PSA subform called -2 Pro-PSA.  It is even more accurate when the results are analyzed using a mathematical formula that provides an overall Prostate Health Index.  The formula divides the Pro-PSA number by the free-PSA. Then the quotient of the two is multiplied by the square root of the total PSA.

“The logic behind the formula is that the higher the Pro-PSA and total PSA and the lower the free-PSA, the more likely the patient has aggressive prostate cancer,” said lead investigator William Catalona, MD, Director of the Clinical Prostate Cancer program at Northwestern University in Chicago.

Dr. Catalona was the first to show, in 1991, that a simple blood test measuring PSA levels could be used to detect PCa.  In this current study, he and his colleagues followed 892 patients from 10 sites. The results, which was scheduled to be published in the May issue of the Journal of Urology, showed the new screening test was particularly useful for patients with a normal prostate exam whose PSA was in the 2-10 ng/mL range.

In their study, the researchers found that an increasing Prostate Health Index was associated with a 4.7-fold increased risk of prostate cancer and a 1.16-fold increased risk of Gleason 7 or greater disease on biopsy. Index results were not associated with age and prostate volume, Dr. Catalona said.

The FDA is currently reviewing the data from this current study.

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