New blood test could avoid 40% prostate biopsies

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A new blood test called IsoPSA may reduce the need for prostate biopsies in more than 40% cases

A new study has proved the accuracy of IsoPSA – a new blood test – in predicting overall risk of prostate cancer than standard prostate-specific antigen (PSA) test. The study was presented  at the 13th Annual Meeting of the American Urological Association (AUA) on May 18 in San Francisco.

Results showed that more than 40 percent of biopsies could have been avoided in both the preliminary study (45.1 percent) and validation study (47 percent) for diagnosis of prostate cancer. IsoPSA use may substantially reduce the need for biopsy, and may thus lower the likelihood of overdetection and overtreatment of nonlethal prostate cancer.

The PSA test is used routinely in many parts of the world for detection of prostate cancer but PSA levels are affected by many factors other than prostate cancer and that leads to a high number of false positives for prostate cancer.

A study published in the New England Journal of Medicine in 2009 stated, “The rate of overdiagnosis of prostate cancer (defined as the diagnosis in men who would not have clinical symptoms during their lifetime) has been estimated to be as high as 50% in the screening group.”

Falsely raised PSA levels are seen in cases of an enlarged prostate or infected prostate, a recent rectal exam, an urinary tract infection and even a lot of sex can falsely increase the PSA reading. The test cannot indicate the difference between a slow-growing cancer and an aggressive cancer.

The study, Prospective Validation of the IsoPSA Assay for Detection of High Grade Prostate Cancer was  led by Eric Klein, M.D. of Cleveland Clinic, who conducted a multicenter confirmation trial and evaluated data including cutoff parameters derived from a preliminary study. The detection of cancer by biopsy was the endpoint.

In Indian males prostate cancer is the second commonest cancer as per data from the Indian Council of Medical Research. The incidence rate in India is 9-10/100000 population

The study was a follow-up to earlier studies which showed that IsoPSA, a protein biomarker, may be an effective test for differentiating between high-grade prostate cancer (Gleason≥7) and low-grade/benign disease (Gleason=6). A Gleason score is derived from 2 examinations of the biopsy — the first evaluating the architectural features of the prostate gland, and the second looking at the level of abnormality of the cell nucleoli. The combined total is the Gleason score and it is used for histopathological staging of prostate cancer.

Prostate cancer is the second most common cause of cancer and the sixth in terms of cancer mortality among men the world over. Experts predict that the number of cases will double by 2020. In Indian males prostate cancer is the second commonest cancer as per data from the Indian Council of Medical Research. The incidence rate in India is 9-10/100000 population which though is lower than USA and Europe.

“To be clinically useful, a biomarker must be both tissue-specific and cancer-specific. While PSA is prostate-specific, it is not specific for prostate cancer, leading to diagnostic inaccuracy and too many unneeded biopsies,” said Dr. Klein, chair of Cleveland Clinic’s Glickman Urological & Kidney Institute. “IsoPSA fulfills both the tissue- and cancer-specificity needed for a useful biomarker, and this validation study shows that it can more accurately detect high-grade cancer and reduce the rate of unneeded biopsies in patients at low risk of this disease.”

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