Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stockholm3.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Active Surveillance for Prostate Cancer. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter Validation of the Stockholm3 Test on Men on Active Surveillance: the CHAS3-Trial
Overview
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.
Detailed description
The CHAS3 trial is a study carried out at several hospitals that follows men with prostate cancer who are being closely monitored through active surveillance. The study looks at how well the Stockholm3 blood test can predict whether the cancer has become more serious when the men later have their scheduled follow-up biopsy.
Men who are already on active surveillance and planned for a routine biopsy may be invited to join. Participants must be alive and must not have started any treatments such as surgery, radiation, hormone therapy, or chemotherapy. To avoid extra procedures, any study samples will be taken at the same time as the patient's regular follow-up visits.
Interventions
- Diagnostic test Stockholm3
Predictive value of Stockholm3 test in a prostate cancer cohort on Active Surveillance (AS) for upgrading on re-biopsy
Primary outcome measures
- Diagnostic accuracy of the Stockholm3 test for detection of histological upgrading to ISUP Grade Group ≥2 at follow-up prostate biopsy [Time frame: At time of follow-up biopsy (baseline visit; Day 0 of study procedures)]
Secondary outcome measures (3)
- Sensitivity and specificity of the Stockholm3 test at predefined risk thresholds (≥11, ≥13, ≥15) for detection of ISUP Grade Group ≥2 prostate cancer [Time frame: At time of follow-up biopsy (baseline visit)]
- Comparative diagnostic accuracy of Stockholm3 test versus PSA density, PSA doubling time, and MRI progression for detection of ISUP Grade Group ≥2 upgrading [Time frame: At time of follow-up biopsy]
- Change in patient-reported quality-of-life scores measured using the EPIC-26 questionnaire following prostate biopsy [Time frame: Baseline and 30 days after prostate biopsy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
Switzerland · 1 center
- Inselspital, University Hospital of Bern — Bern
Identifiers
NCT: NCT07478536 · CHAS3-2026-NG-001