Stockholm3
Clinical Development in the United States

Stockholm3 is an investigational in vitro diagnostic test under clinical evaluation in the United States for potential use in prostate cancer screening to identify men at risk of aggressive (Grade Group ≥2) prostate cancer. Stockholm3 has not been cleared or approved by the U.S. Food and Drug Administration.

Prostate cancer

• Prostate cancer is a major cause of cancer-related death [ref]

• Early-stage disease is typically associated with good outcomes after treatment. Data from Surveillance, Epidemiology, and End Results (SEER) shows that men with prostate cancer detected at an early stage have an approximately 100% five-year survival rate, whereas those diagnosed at a late stage have a five-year survival of approximately 32% [ref]

• For many years, early detection has relied on the prostate-specific antigen (PSA) blood test. [ref]

PSA-based screening has improved early detection of prostate cancer but has recognized limitations. A major problem with PSA is that it misses aggressive cancers in men with low PSA levels, below commonly used cut-offs (3 ng/ml or 4 ng/ml). Up to 50% of aggressive prostate cancers occur at these low PSA levels, and some of these cancers may be more deadly than cancers found at higher PSA levels.
At the same time, PSA often rises for reasons unrelated to cancer, leading to many false alarms. These false positive test results can cause unnecessary biopsies and associated downstream harms, anxiety, and healthcare costs. PSA also has limited ability to distinguish between slow-growing, harmless cancers and aggressive cancers that require treatment. [ref]

Why Improved Screening Is Needed

Stockholm3

Stockholm3 is a blood-based test designed to improve prostate cancer screening accuracy. Stockholm3 combines blood-based biomarkers, genetic risk information, and clinical risk factors to estimate a man’s risk of having aggressive prostate cancer.

Stockholm3 has been evaluated in prospective screening studies involving more than 90,000 men.

Published studies have reported improved detection and discrimination of aggressive prostate cancer compared to PSA-based strategies.

Clinical Evidence

Peer-reviewed screening trials have evaluated Stockholm3 in population-based settings and structured diagnostic pathways. Across these studies, risk-based screening strategies incorporating Stockholm3 have been associated with:

• Improved detection of aggressive prostate cancers (Grade Group ≥2 cancer)

• Identification of aggressive cancers in men with lower PSA levels

• Reduction in unnecessary biopsies in men with elevated PSA levels

Detailed clinical performance data are available for healthcare professionals.

  • 1. Grönberg et al. Prostate cancer screening in men aged 50–69 years (STHLM3): a prospective population-based diagnostic study. The Lancet Oncology. 2015

    Nordström et al. Prostate Cancer Screening Using a Combination of Risk-Prediction, MRI, and Targeted Prostate Biopsies. The Lancet Oncology. 2021

    Grönberg et al. Prostate Cancer Diagnostics Using a Combination of the Stockholm3 Blood Test and Multiparametric Magnetic Resonance Imaging. European Urology. 2018

    Viste et al. Effects of replacing PSA with Stockholm3 for diagnosis of clinically significant prostate cancer in a healthcare system - the Stavanger experience. SJPHC. 2020

    Palsdottir, T et. al. The Capio Prostate Cancer Center Model for Prostate Cancer Diagnostics – Real world evidence from 2018 to 2022. European Urology Opean Science. 2024 Jan 25

    Elyan et al. Prospective Multicenter Validation of the Stockholm3 Test in a Central European Cohort. Eur Urol Focus. 2023 Oct 7

    Fredsoe et al. Results from the PRIMA Trial: Comparison of the STHLM3 Test and Prostate-specific Antigen in General Practice for Detection of Prostate Cancer in a Biopsy-naïve Population. Eur Urol Oncol. 2023 Oct

    Vigneswaran et al. Stockholm3 in a Multiethnic Cohort for Prostate Cancer Detection (SEPTA): A Prospective Multicentered Trial. J Clin Oncol. 2024 Jul 22

    Tilki et al. External Validation of Stockholm3 in a Retrospective German Clinical Cohort. Eur Urol Focus. 2024 Aug 6

    2. Viste et al. Effects of replacing PSA with Stockholm3 for diagnosis of clinically significant prostate cancer in a healthcare system - the Stavanger experience. SJPHC. 2020

    Palsdottir, T et. al. The Capio Prostate Cancer Center Model for Prostate Cancer Diagnostics – Real world evidence from 2018 to 2022. European Urology Opean Science. 2024 Jan 25

    3. Grönberg et al. Prostate cancer screening in men aged 50–69 years (STHLM3): a prospective population-based diagnostic study. The Lancet Oncology. 2015

    Eklund et al. The Stockholm-3 (STHLM3) Model can Improve Prostate Cancer Diagnostics in Men Aged 50–69 yr Compared with Current Prostate Cancer Testing. European Urology Focus. 2016

    Grönberg et al. Prostate Cancer Diagnostics Using a Combination of the Stockholm3 Blood Test and Multiparametric Magnetic Resonance Imaging. European Urology. 2018

    Waldén M et al. A Head-to-head Comparison of Prostate Cancer Diagnostic Strategies Using the Stockholm3 Test, Magnetic Resonance Imaging, and Swedish National Guidelines: Results from a Prospective Population-based Screening Study. European Urology Open Science. 2022

    Vigneswaran et al. Stockholm3 validation in a multi-ethnic cohort for prostate cancer (SEPTA) detection: A multicentered, prospective trial. JCO supplements, ASCO-GU 2024 presentation, 2024, Jan 25. Vigneswaran et al. Stockholm3 in a Multiethnic Cohort for Prostate Cancer Detection (SEPTA): A Prospective Multicentered Trial. J Clin Oncol. 2024 Jul 22

    Tilki et al. External Validation of Stockholm3 in a Retrospective German Clinical Cohort. Eur Urol Focus. 2024 Aug 6

    4. Bergman et al. Structured care for men who want to get tested for prostate cancer – findings from Capio Prostate Cancer Center. Läkartidningen. 2018;115:FCDT

    Viste et al. Effects of replacing PSA with Stockholm3 for diagnosis of clinically significant prostate cancer in a healthcare system - the Stavanger experience. SJPHC. 2020, Söderbäck et al. Improved prostate cancer diagnostics with a structured pathway including Stockholm 3 test, MRI and targeted perineal biopsies. Läkartidningen. 2023

    Mcleod et al. Cost Effectiveness of Prostate Cancer Testing incorporating Stockholm3 and MRI versus standard of care. EAU 2024, April 7

    Hao S et al. Cost-effectiveness of Stockholm3 test and magnetic resonance imaging in prostate cancer screening: a microsimulation study. European Urology. 2022.

    5. Thompson et al. Prevalence of Prostate Cancer among Men with a Prostate-Specific Antigen Level ≤4.0 ng per Milliliter. NEJM 2004

    Naji et al. Digital Rectal Examination for Prostate Cancer Screening in Primary Care: A Systematic Review and Meta-Analysis. Ann Fam Med, 2018

    Krilaviciute et al. Digital Rectal Examination Is Not a Useful Screening Test for Prostate Cancer. European Urology Oncology, 2023

    6. Eggener S. Comment - Prostate cancer screening in men aged 50 to 69 years (STHLM3): A prospective population-based diagnostic study. Urol Oncol. 2017 Mar

    7. Grönberg et al. Prostate cancer screening in men aged 50–69 years (STHLM3): a prospective population-based diagnostic study. The Lancet Oncology. 2015

    Nordström et al. Prostate Cancer Screening Using a Combination of Risk-Prediction, MRI, and Targeted Prostate Biopsies. The Lancet Oncology. 2021

    Grönberg et al. Prostate Cancer Diagnostics Using a Combination of the Stockholm3 Blood Test and Multiparametric Magnetic Resonance Imaging. European Urology. 2018

    Viste et al. Effects of replacing PSA with Stockholm3 for diagnosis of clinically significant prostate cancer in a healthcare system - the Stavanger experience. SJPHC. 2020

    Palsdottir, T et. al. The Capio Prostate Cancer Center Model for Prostate Cancer Diagnostics – Real world evidence from 2018 to 2022. European Urology Opean Science. 2024 Jan 25

    Elyan et al. Prospective Multicenter Validation of the Stockholm3 Test in a Central European Cohort. Eur Urol Focus. 2023 Oct 7

    Fredsoe et al. Results from the PRIMA Trial: Comparison of the STHLM3 Test and Prostate-specific Antigen in General Practice for Detection of Prostate Cancer in a Biopsy-naïve Population. Eur Urol Oncol. 2023 Oct

    Vigneswaran et al. Stockholm3 in a Multiethnic Cohort for Prostate Cancer Detection (SEPTA): A Prospective Multicentered Trial. J Clin Oncol. 2024 Jul 22

    Tilki et al. External Validation of Stockholm3 in a Retrospective German Clinical Cohort. Eur Urol Focus. 2024 Aug 6

    Vigneswaran et al. Stockholm3 validation in a multi-ethnic cohort for prostate cancer (SEPTA) detection: A multicentered, prospective trial. JCO supplements, ASCO-GU 2024 presentation, 2024, Jan 25

    Waldén M et al. A Head-to-head Comparison of Prostate Cancer Diagnostic Strategies Using the Stockholm3 Test, Magnetic Resonance Imaging, and Swedish National Guidelines: Results from a Prospective Population-based Screening Study. European Urology Open Science. 2022

    Söderbäck et al. Improved prostate cancer diagnostics with a structured pathway including Stockholm 3 test, MRI and targeted perineal biopsies. Läkartidningen. 2023,

    Mcleod et al. Cost Effectiveness of Prostate Cancer Testing incorporating Stockholm3 and MRI versus standard of care. EAU 2024, April 7

    Hao S et al. Cost-effectiveness of Stockholm3 test and magnetic resonance imaging in prostate cancer screening: a microsimulation study. European Urology. 2022

    Mottet et al. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021

    Wei, J.T., et al., Early Detection of Prostate Cancer: AUA/SUO Guideline Part I: Prostate Cancer Screening. J Urol, 2023.

    8. Thompson et al. Prevalence of Prostate Cancer among Men with a Prostate-Specific Antigen Level ≤4.0 ng per Milliliter. NEJM 2004

    Hamdy et al. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. NEJM, 2023

    Loeb, et al. Systematic review of complications of prostate biopsy. Eur Urol. 2013

    9. Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763. PMID: 36633525, Cancer Facts and Figures, American Cancer Society, 2023

    10. Viste et al. Effects of replacing PSA with Stockholm3 for diagnosis of clinically significant prostate cancer in a healthcare system - the Stavanger experience. SJPHC. 2020

    Palsdottir, T et. al. The Capio Prostate Cancer Center Model for Prostate Cancer Diagnostics – Real world evidence from 2018 to 2022. European Urology Opean Science. 2024 Jan 25