Stockholm3 included in American guidelines as a primary test for early detection of prostate cancer
Stockholm3 has been included as a primary test in the revised 2023 American Urological Association (AUA) guidelines for early detection of prostate cancer. The AUA stated that the PSA blood test remains the first-line screening test of choice and, at the same time, that Stockholm3 has a higher predictive accuracy compared to PSA alone, with the advantage of reducing unnecessary biopsies. In addition, Stockholm3 is recommended as a secondary test for men with elevated PSA levels as well as after a negative biopsy.
“This is the first mention of any test in international guidelines for primary prostate cancer testing since PSA was introduced more than 35 years ago, and a major step forward for Stockholm3 in setting a new standard of care for early detection of prostate cancer. Entering the US market is one of our top priorities and we expect that the new AUA guidelines will increase the interest in Stockholm3,” says David Rosén, CEO of A3P Biomedical.
In its review, the AUA stated that the PSA blood test remains the first-line screening test of choice based on randomized trials of PSA-based screening showing reductions in metastasis and prostate cancer death. At the same time, the AUA stated that Stockholm3 as a primary prostate cancer test has a higher predictive accuracy compared to PSA alone and the advantage of reducing unnecessary biopsies. The AUA also stated that further validation in diverse populations to confirm findings in Europe will be necessary to move forward into practice.
“The evaluation of Stockholm3 in diverse populations is well underway with the multi-centered, multi-ethnic, North American SEPTA-STHLM3 trial that closes recruitment in June 2023. We expect to be able to present results from this study in 2024, which will provide further clinical evidence and hopefully support a broader use of Stockholm3 in one of the largest global markets”, David Rosén concluded.
In the AUA guidelines, Stockholm3 is also recommended as a next test for patients with elevated PSA (conditional recommendation, grade C) as well as a next test after a negative biopsy (conditional recommendation, grade C).
Prostate cancer is the most common form of cancer in American men. In 2023, it is estimated that 288,300 men will be diagnosed and that 34,700 will die from prostate cancer in the United States. Early detection is crucial for improved treatment outcome and decreased mortality in prostate cancer.