A new blood test is showing stronger results than the long-used PSA test in spotting aggressive prostate cancer.

In a study published in the Annals of Internal Medicine, researchers from the Karolinska Institutet in Sweden assessed the test, called Stockholm3, in more than 12,000 men aged 50 to 74, most of them Swedish or European.

All participants took both the PSA test and Stockholm3, and researchers followed them for two years. During that time, 443 men were diagnosed with aggressive prostate cancer.

Stockholm3 detected 90 percent of aggressive prostate cancer cases, compared with 74 percent for PSA tests. It also missed “significantly fewer” serious cancer cases than PSA, while the number of men incorrectly classified as high-risk was similar for both tests, according to a press release.

Thorgerdur Palsdottir, a researcher at the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, said one of the major challenges in prostate cancer is identifying the cases that are “truly dangerous.”

“Our results show that Stockholm3 identifies significantly more aggressive cancer cases than PSA, without increasing the number of unnecessary follow-ups,” she said.

“These results point toward a potential change in how prostate cancer screening can be conducted,” Palsdottir added. “A more precise blood test could enable earlier detection of aggressive disease while reducing the number of unnecessary follow-up examinations and procedures.”

Study co-author Hari Vigneswaran, MD, chief medical officer of Stockholm3-maker A3P Biomedical, said PSA has been the standard for prostate cancer screening since the 1990s despite its “well-documented limitations.”

“It leads to invasive and costly follow-up testing, contributes to over-diagnosis of non-aggressive cancers and, most importantly, it misses a substantial share of aggressive disease,” Vigneswaran said.

He said data from the National Cancer Institute’s SEER database show metastatic prostate cancer has risen over the past decade, suggesting that “we have not improved early detection of the aggressive, curable disease that screening is meant to catch.”

“The goal of screening is to find the cancers that need treatment while they are still curable, without raising the number of men who screen positive but don’t have aggressive disease,” he said.

Vigneswaran said Stockholm3 could reduce the need for unnecessary MRIs and biopsies.

He also said the findings have limitations. Stockholm3 is an investigational device and is not currently available for sale in the US. The test estimates a man’s risk of aggressive prostate cancer, but a biopsy remains the gold standard for confirming the disease.

The company plans to seek FDA approval for routine screening use and will “generate the evidence needed to support that pathway, including U.S. data,” Vigneswaran said.

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