Stockholm3 has been mentioned as a biomarker test in the revised 2023 American Urological Association (AUA) guidelines for early detection of prostate cancer. The AUA guidelines cite a publication (Grönberg et al. 2015, Lancet Oncology1) which has shown that Stockholm3 has a higher predictive accuracy compared to PSA alone, with the advantage of reducing unnecessary biopsies. The AUA guidelines further state that clinicians may use adjunctive biomarkers, such as Stockholm3, for men with elevated PSA levels as well as after a negative biopsy when the decision to perform a re-biopsy would be affected.
The AUA guidelines state 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. The AUA guidelines cite a publication (Grönberg et al. 2015, Lancet Oncology1) which has shown that Stockholm3 has a higher predictive accuracy compared to PSA alone, with the advantage of reducing unnecessary biopsies. The AUA states 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-centred, 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”, says David Rosén, CEO of A3P Biomedical.
The AUA guidelines state, “Clinicians may use adjunctive urine or serum markers when further risk stratification would influence the decision regarding whether to proceed with biopsy – Conditional Recommendation; Evidence Level: Grade C.” The guidelines also state, “After a negative biopsy, clinicians may use blood, urine, or tissue-based biomarkers selectively for further risk stratification if results are likely to influence the decision regarding repeat biopsy or otherwise substantively change the patient’s management – Conditional Recommendation; Evidence Level: 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.
1Gronberg H, Adolfsson J, Aly M et al: Prostate cancer screening in men aged 50-69 years (sthlm3): A prospective population-based diagnostic study. Lancet Oncol 2015; 16: 1667