Each year, more than one million men in the United States have a prostate biopsy due to an elevated PSA. The majority of these biopsies show either no prostate cancer or low-risk cancer, meaning the biopsy was not necessary. Although screening for prostate cancer with serum PSA has reduced mortality from prostate cancer, it has also led to an increased number of unnecessary biopsies. A simple new test, the 4Kscore, is set to change that, and yet most men have never heard of it.
The 4Kscore, named because it measures four kallikrein proteins found in the blood, is the latest prostate cancer screening tool. It accurately predicts whether cancer is present, allowing physicians and patients to decide whether to move forward with a biopsy.
Urologists at Sylvester Comprehensive Cancer Center, Dipen J. Parekh, M.D., and Sanoj Punnen, M.D., have completed the first U.S. clinical trial of the 4Kscore. It combines measurement of the four proteins 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.
“Our trial confirmed what research in Europe had originally revealed, that the 4Kscore accurately identifies men with high-grade prostate cancer,” said Parekh, head of urology at UHealth – University of Miami Health System. “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 presented their findings at the 2015 Genitourinary Cancers Symposium.
Torsan Cowart of Boynton Beach, was one of many men who had never heard of the 4Kscore. When his PSA levels came back higher than normal, Cowart was unsure whether to move forward with a biopsy.
“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,” said Parekh, who is professor and chairman of urology at the University of Miami Miller School of Medicine. “In our study we found that 43 percent of unnecessary biopsies would have been avoided with the 4Kscore.”
Doctors recommended that Cowart have the 4Kscore screening, which was as simple as ordering a blood test. “I was told it was a new test that was able to give you a risk percentage of whether you have cancer,” Cowart said. “My PSA was in a high range, so I wanted to be sure. I agreed to take it.”
After receiving his 4Kscore results, Cowart had no doubt that he needed to move forward with a biopsy, which ultimately came back positive for prostate cancer. But while many men like Cowart are receiving news that further treatment is required, just as many are determining that a biopsy is unnecessary, thanks to the 4Kscore.
Parekh and Punnen 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.
Published in European Urology, Parekh and Punnen showed that the 4Kscore has 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.
The study reviewed 1,012 men from 26 institutions around the U.S. 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.
“Physicians and patients now have a tool that will better enable them to decide whether to undergo or forgo a biopsy, and they can both walk away knowing with almost complete certainty that the decision they made was correct,” said Punnen, assistant professor of urology at the University of Miami Miller School of Medicine.
Above content is provided by Sylvester Comprehensive Cancer Center