TEST:

Stockholm3

In this screening cohort with short-term follow-up, Stockholm3 provided greater clinical net benefit than PSA for detecting csPC, driven by fewer false-negative results, although follow-up was limited to 2 years. Swedish Research Council, Swedish Prostate Cancer Society, Stockholm Region, and the Swedish Cancer Society.

P=N/A, N=350, Not yet recruiting, Insel Gruppe AG, University Hospital Bern | Initiation date: Apr 2026 --> Jul 2026

In a non-referral setting, Stockholm3 confirmed good diagnostic performance for csPCa. These findings support its use as part of the primary diagnostic work-up in similar clinical settings.

P=N/A, N=350, Not yet recruiting, Insel Gruppe AG, University Hospital Bern

"A landmark study with nine-year follow-up, recently published in European Urology, demonstrates that Stockholm3 can detect aggressive and potentially lethal prostate cancers among men with PSA levels in the 1.5 - 3 ng/ml range. The study showed that these men, who had a positive Stockholm3, were nine times more likely (hazard ratio of 8.8) to have a high-risk biochemical recurrence after treatment than men with PSA 3 ng/ml or higher, and a negative Stockholm3. Approximately 20-30% of men aged 50-75 years have a PSA between 1.5 – 3 ng/ml."

Some men with PSA <3 ng/ml harbor aggressive PCa with a substantial risk of recurrence after upfront curative treatment. Risk predictive blood tests, such as Stockholm3, used at lower PSA thresholds, can identify these men, while few clinically important cancers are missed when biopsy is deferred with PSA ≥3 ng/ml but low Stockholm3 scores.

P=N/A, N=7500, Active, not recruiting, Karolinska Institutet

For most of our 26 patients on AS with a Stockholm3 score of <15, confirmatory biopsy revealed GG 1 and benign histology. A confirmatory biopsy should be recommended for all patients with PI-RADS ≥4 lesions irrespective of their Stockholm3 score, but could be avoided in cases with negative MRI findings and a Stockholm3 score of <15.

We observed a substantial testing rate of 33% between STHLM3-MRI screening rounds, but few PCa cases were detected among men with lower risk. Most cancers were diagnosed in the elevated-risk group. A reduction in opportunistic testing in lower-risk groups will be crucial for optimising the benefits of future screening programmes.