Stockholm3 included in the American Urological Association (AUA) guidelines for early detection of prostate cancer
May 4, 2023
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
About A3P Biomedical
A3P Biomedical is a company that specializes in advanced prostate cancer diagnostics. A3P’s main product, Stockholm3, is a clinically and commercially validated blood test for early detection and risk stratification of aggressive prostate cancer. A3P Biomedical is headquartered in Stockholm, Sweden. For more information, please visit www.a3p.com
About Stockholm3
Stockholm3 is a blood-based test, that runs a combination of protein biomarkers, genetic biomarkers and clinical information through an algorithm to find the probability of clinically significant cancer at biopsy.
Stockholm3 has been evaluated in clinical studies including more than 90,000 men. It is extensively tested in large population-based screening trials, as well as in real world clinical utility studies in primary care, as a reflex test to PSA at values 1.5-20 ng/ml. Benefits include the ability to reduce unnecessary MRIs, benign and Grade Group 1 prostate biopsies for men with elevated PSA, while simultaneously improving detection of clinically significant cancers in men with low or normal PSA values. Using Stockholm3 leads to a more accurate risk assessment than the current PSA standard. Stockholm3 detects 40-90% more men with aggressive prostate cancer and, at the same time, reduces over-detection by 40-50% compared to PSA.
Multiple Stockholm3 studies have been published in high-impact journals such as The Lancet Oncology, Journal of Clinical Oncology, and European Urology. The studies address both the specificity and sensitivity of Stockholm3 in multi-ethnic populations as well as health-economic benefits of implementing it in clinical care. For more information about our clinical studies please visit www.a3p.com.
About prostate cancer
Prostate cancer is the most common cancer in men. In 2020, the global incidence of new prostate cancer cases was 1.4 million, and prostate cancer specific mortality 370,000. Global prostate cancer incidence and mortality is expected to rise by 100% and 85% respectively by 2040, driven by an ageing population.
Press contact:
Cecilia Edström
cecilia.edstrom@a3p.com
+46 72 226 2328