A new blood test is raising hopes for faster and more accurate detection of aggressive prostate cancer, potentially outperforming the long-standing prostate-specific antigen test.
The test, called Stockholm3, demonstrated strong results in a clinical trial conducted by researchers at the Karolinska Institutet in Sweden.
According to a study published in the Annals of Internal Medicine, the test identified 90% of aggressive prostate cancer cases, compared to 74% detected by standard PSA screenings.
The study involved more than 12,000 men, mostly Swedish or European, aged 50 to 74, who were tested with both PSA and Stockholm3 and monitored for two years.
During that period, 443 participants were diagnosed with aggressive prostate cancer, giving researchers a large sample to compare performance between the two methods.
The team found that Stockholm3 missed “significantly fewer” serious cases than PSA, while the number of men incorrectly classified as high-risk was roughly the same for both tests.
Thorgerdur Palsdottir, a researcher at the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet, said one of the major challenges in prostate cancer screening is being able to identify 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,” Palsdottir said.
She added that the findings suggest prostate screening “could change” with a more precise blood test that allows earlier detection of aggressive disease while cutting back on unnecessary procedures.
Hari Vigneswaran, chief medical officer of A3P Biomedical, Stockholm3’s manufacturer, described the data as “promising” in an interview with Fox News Digital.
He noted that the PSA test has been the standard since the 1990s, despite what he called “well-documented limitations,” such as causing over-diagnosis and missing some of the most dangerous cancers.
“When aggressive prostate cancer is found while still confined in the prostate, the five-year survival is close to 100%,” Vigneswaran said, emphasizing the importance of early detection.
He cited data from the National Cancer Institute’s SEER database showing an increase in metastatic prostate cancer over the past decade, suggesting early detection rates have not improved.
“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.
According to Vigneswaran, Stockholm3 may also help lower the number of men who undergo unnecessary MRIs and biopsies because of false alarms from the current PSA test.
However, the study’s authors acknowledged some limitations. Stockholm3 remains an investigational device that is not yet approved for sale or use in the United States.
While the test estimates a man’s risk of aggressive prostate cancer, a biopsy continues to serve as the gold standard for confirming the disease.
Vigneswaran said the company plans to seek FDA approval and will continue to collect U.S. data to support that process.
The research team believes the new approach could improve early detection strategies for prostate cancer while reducing the strain of overtesting on patients and healthcare systems.
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