Clinical trial · Observational
Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 Trial)
Multicenter Validation of the Stockholm3 Test on Men on Active Surveillance: the CHAS3-Trial
NCT07478536CI-TRIAL-00115373CHAS3not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Active Surveillance for Prostate Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stockholm3 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Stockolm3 Blood test in prostate cancer patient under active surviellance
- description
- Diagnostic procedure
- interventionNames
- Diagnostic Test: Stockholm3
Primary outcomes (1)
- measure
- Diagnostic accuracy of the Stockholm3 test for detection of histological upgrading to ISUP Grade Group ≥2 at follow-up prostate biopsy
- timeFrame
- At time of follow-up biopsy (baseline visit; Day 0 of study procedures)
- description
- 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).
Secondary outcomes (3)
- measure
- Sensitivity and specificity of the Stockholm3 test at predefined risk thresholds (≥11, ≥13, ≥15) for detection of ISUP Grade Group ≥2 prostate cancer
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Adult Men ≥ 18 y. o. * Men with low-risk prostate cancer (D'Amico risk classification) currently undergoing Active Surveillance (AS) * First inclusion in Active Surveillance (AS) after 1st January 2022. * Scheduled for follow-up with systematic and/or Magnetic Resonance Imaging (MRI)-targeted (fusion) prostate biopsies - Prostate Magnetic Resonance Imaging (MRI) performed within the past three months available Exclusion Criteria: * \- Prior prostate cancer treatment (surgery, radiation, chemotherapy, hormonal therapy). * Patient with intermediate- or high-risk prostate cancer * Urinary catheterization within the past 6-8 weeks * Contraindications to Magnetic Resonance Imaging (MRI) or biopsy
References
Publications (0)
Data not yet available
No reference posted for this study.