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A new test could make it easier to detect high-risk prostate cancer cases earlier.
The blood test, called Stockholm3, is showing promise in clinical trials, beating out the traditional, standard prostate-specific antigen (PSA) test.
In a new study published in the Annals of Internal Medicine, researchers from the Karolinska Institutet in Sweden studied the test’s efficacy in more than 12,000 men – mostly Swedish or European – aged 50 to 74.
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All participants were tested with PSA and Stockholm3 and were followed for two years. During the follow-up period, 443 men were diagnosed with aggressive prostate cancer.
Stockholm3 detected 90% of aggressive prostate cancer cases compared to 74% for PSA tests.
Stockholm3 missed “significantly fewer” serious cancer cases than PSA. The number of men incorrectly classified as high-risk was similar across both tests, according to a press release.
Thorgerdur Palsdottir, a researcher at the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, wrote in a statement that one of the major challenges in prostate cancer is being able to identify the cases that are “truly dangerous.”
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“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,” the researcher 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, commented on these “promising” findings in an interview with Fox News Digital.
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He confirmed that PSA has been the standard for prostate cancer screening since the 1990s, despite its “well-documented limitations.”
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“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.
When aggressive prostate cancer is found while still confined in the prostate, the five-year survival rate is close to 100%, which highlights the importance of early detection, according to the doctor.
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Data from the National Cancer Institute’s SEER database show that 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,” Vigneswaran said.
“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.
Stockholm3 could reduce the need for unnecessary MRIs and biopsies, according to the researcher.
The findings did have some limitations. Stockholm3 is an investigational device and is not currently available for sale in the U.S., Vigneswaran noted.
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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 to use the test for routine screening and will “generate the evidence needed to support that pathway, including U.S. data,” Vigneswaran said.
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