Stockholm3 for prostate cancer screening

The technology described in this briefing is Stockholm3. It is used to help predict risk of prostate cancer in people aged 45 to 74 years with prostate‑specific antigen (PSA) of at least 1.5 nanograms per ml and no previous diagnosis of prostate cancer.

The innovative aspects are that Stockholm3 combines protein biomarkers, genetic markers and clinical data with an algorithm to help identify prostate cancer.

The intended place in therapy would be as an addition to standard care for people with a PSA level of at least 1.5 nanograms per ml. The technology could be used in primary care or secondary care settings to test for prostate cancer.

The main points from the evidence summarised in this briefing are from 7 diagnostic accuracy studies, using mixed methods, including a total of 460,503 people for prostate cancer screening in primary care and secondary care. The evidence suggests that Stockholm3 is more effective at predicting risk of prostate cancer than PSA testing alone for people aged 45 to 74.

Key uncertainties around the evidence or technology are that there is currently no evidence assessing the effect of the test on clinical decision making and long-term clinical outcomes in the NHS. Data about Black, Asian, and minority ethnic populations is currently limited.

Experts agreed that the technology has the potential to improve diagnostic accuracy leading to a reduction in unnecessary MRI and biopsies. The technology is not yet used in the NHS and the main barrier to adoption is the lack of current initiatives or programmes for prostate cancer screening in primary care, and the additional financial cost to the NHS. Experts had mixed views on the most appropriate care setting and treatment pathway, with several options possible in both primary and secondary care. A patient organisation commented its concerns with adopting the device are that there is no defined place in the pathway for it to be rolled out and it questioned whether there is sufficient infrastructure and workforce in place within pathology for nationwide adoption.

The cost of Stockholm3 is £350 per unit (excluding VAT) less applicable volume discounts. This includes the analysis of the blood test. There are additional costs such as for phlebotomy, and collection and transport of the samples to the reference laboratory. Some costs may already be captured in standard care costs depending on the care setting and proposed pathway.