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Opko 4Kscore Confirmed by UM Urologists

UHealth
University Of Miami
Miller School of Medicine
03/11/2015

More than one million men have a prostate biopsy each year in the United States. The majority of these biopsies show either no prostate cancer or low-risk cancer, meaning the biopsy was unnecessary. Although screening for prostate cancer with serum PSA has reduced mortality from prostate cancer, it has come at the cost of many men having to undergo further testing, such as a biopsy, and so physicians and patients have been searching for a better prostate cancer screening tool. The 4Kscore is the solution.

University of Miami urologists Dipen J. Parekh, M.D., and Sanoj Punnen, M.D., have completed the first U.S. clinical trial of the 4Kscore. This new prostate cancer screening tool combines measurement of four kallikrein proteins found in the blood with a patient’s age, digital rectal examination findings and prior biopsy status to provide the likelihood of the patient having a high-grade cancer.

Parekh and Punnen’s study, published in European Urology, found that the 4Kscore showed a near-perfect calibration in identifying patients most likely to benefit from biopsy because of a high probability of having a tumor that would require treatment. The risk of missing a high-grade cancer with the 4Kscore was minimal.

“Our trial confirmed what research in Europe had originally revealed, that the 4Kscore accurately identifies men with high-grade prostate cancer,” said Parekh, professor and Chair of the Department of Urology at the Miller School of Medicine. “This is significant due to the ongoing criticism of PSA being used as a primary marker for prostate cancer because it leads to over-diagnosis and over-treatment. The 4Kscore rectifies that problem.”

“The 4Kscore is a useful tool in selecting men who are likely to have high-grade disease and most likely to benefit from a prostate biopsy versus those men with no cancer or indolent cancer,” added Punnen, who joined Parekh in presenting their findings at the 2015 Genitourinary Cancers Symposium.

The study reviewed 1,012 men from 26 institutions around the United States between 2013 and 2014. The 4Kscore showed near-perfect prediction of the probability of high-grade cancer. There also was no discrepancy in results when comparing African-American and Caucasian men. The test performed equally well for both demographics.

“In the past few years, there has been much discussion not only on the efficacy of the PSA test, but also on when biopsies should be performed. The 4Kscore resolves that dilemma,” Parekh said. “In our study we found that 43 percent of unnecessary biopsies would have been avoided with the 4Kscore.”

Parekh and Punnen, assistant professor at the Miller School, conclude that the 4Kscore will lead to a “drastic reduction” in the number of biopsies performed, potentially adding up to $1 billion in savings for the U.S. health care system. In addition, thousands of men will be spared the possible complications that are attributed to prostate biopsy, such as urinary incontinence, bleeding and emotional distress.

“Physicians and patients now have a tool that will better enable them to decide whether to undergo or forgo a biopsy,” Punnen said, “and they can both walk away knowing with almost complete certainty that the decision they made was correct.”