What is the Stockholm3 test?
The Stockholm3 test is a blood-based prostate cancer test that predicts the risk for aggressive prostate cancer at biopsy by analyzing five protein markers, more than 100 genetic markers and clinical data. The Stockholm3-test is currently available for clinical use in Sweden, Norway, Denmark and Finland.
Background to the Stockholm3 test
Currently PSA is used to diagnose prostate cancer. However, the PSA-test cannot distinguish between aggressive and benign cancer and is often false positive. Therefore, men who do not have cancer, or have an indolent form of cancer that does not need treatment go through unnecessary and painful prostate biopsies. In addition, PSA misses many men with aggressive cancer and the result from a PSA test is often difficult for the treating doctor to interpret.
Advantages with the Stockholm3 test compared to current clinical practice
- Increases the detection of aggressive cancers. The Stockholm3 test approximately doubles the number of men found with aggressive prostate cancer compared to clinical practice.
- Reduces the number of men that need to undergo unnecessary biopsies. The Stockholm3 test reduces the number of unnecessary biopsies by 50% compared to clinical practice.
- Finds aggressive cancer in men with low PSA-values. The Stockholm3 test can find aggressive cancer in men with PSA levels of 1.5-3 ng/ml. This is cancer that often goes undetected today.
- Provides an answer with a clear and easy-to-interpret recommendation. The Stockholm3 test provides a clear and easy-to-interpret recommendation. This makes it easier for the treating doctor to make a decision on potential further actions. It also helps the man to get a better understanding of his individual risk of getting prostate cancer. For example, nearly half of the men aged 50-70 years have a very low risk profile and do not need to take a new test until after 6 years
Evaluation of the Stockholm3 test
The Stockholm3 test was evaluated in the STHLM3 trial with nearly 60,000 men from Sweden that was carried out by researchers at Karolinska Institutet in 2012-2014. Stockholm3 has been clinically validated on nearly 10,000 men in Sweden, Norway and Finland. Additional validation studies have been carried out in Germany, Holland and the UK. Studies validating the test on a non-Caucasian population (e.g. Hispanics, African American, Asians) will be started in 2020.
Interpretation of the answer from the Stockholm3 test
The result from the Stockholm3 test consists of an answer and an easy-to-interpret recommendation. The answer from the Stockholm3 test can be negative or positive. If negative, the man has a low or normal risk for prostate cancer with recommended follow-up in 6 years respective 2 years. If the answer is positive the man is recommended to be referred to a urologist. Depending on risk level a prostate volume cut-off is set. A urologist measures the prostate volume and conducts a digital rectal exam. If the prostate volume is smaller than the cut-off and or the digital rectal exam is positive a biopsy is recommended. Otherwise a new Stockholm3 test is recommended in 2 years.
Who should not take the Stockholm3 test?
The Stockholm3 test has no proven value for men with a known prostate cancer. The value of taking the test for men who have recently been through biopsy and evaluation with urologist can be discussed. The Stockholm3 test should not be taken on men who are being followed up after a previous prostate cancer. The Stockholm3 test does not replace biopsy for men on active monitoring. The Stockholm3 test has not been evaluated on men below 50 year or men above 70 years. There is no scientific evidence that it is of any benefit to find prostate cancer in men above 75 years old.
Further research on Stockholm3
Research on Stockholm3 is led by Henrik Grönberg’s research team at Karolinska Institutet. Approximately 35 researchers in his group are dedicated to improve prostate cancer diagnostics. The scientific results have been published in leading scientific journals. Research financing has been provided by the Swedish Research Council, Erling Persson Foundation, KAW and EIT Health.
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Möller A, et al. The Stockholm3 blood-test predicts clinically-significant cancer on biopsy: independent validation in a multi-center community cohort. Prostate Cancer Prostatic Dis. 2018 Aug 31. doi: 10.1038/s41391-018-0082-5. [Epub ahead of print] PubMed PMID: 30171228.
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 Defined as Gleason Score≥7
 Total PSA, free PSA, HK2, MSMB and MIC1
 Age, earlier prostate biopsy, family history of prostate biopsy and use of 5-alfareducase inhibitors. In addition digital rectal examination (DRE) and prostate volume is used on men referred to urologist