Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 Trial)

Condition(s) studied

Investigational drug(s) / intervention(s)

Stockholm3: Predictive value of Stockholm3 test in a prostate cancer cohort on Active Surveillance (AS) for upgrading on re-biopsy

Study summary

The CHAS3 trial studies whether the Stockholm3 blood test can reliably detect if prostate cancer becomes more aggressive in men who are being carefully monitored instead of treated right away (active surveillance). The goal is to see if this test can help doctors safely follow patients with fewer invasive procedures, such as repeated biopsies.

Eligibility

Primary outcome measure(s)

• Diagnostic accuracy of the Stockholm3 test for detection of histological upgrading to ISUP Grade Group ≥2 at follow-up prostate biopsy — At time of follow-up biopsy (baseline visit; Day 0 of study procedures)
  The Stockholm3 risk score (cutoff ≥11) will be evaluated for its ability to predict histological upgrading to ISUP Grade Group ≥2 at scheduled follow-up prostate biopsy in men undergoing active surveillance for prostate cancer. Diagnostic performance will be quantified using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC).

Trial sites (1)

More Insel Gruppe AG, University Hospital Bern trials in Switzerland

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