Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 Trial)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
- 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
Trial population
Male Patients with a prostate cancer diagnose under active surveillance being treated on Swiss Hospitals
Trial design
Design model
Case-crossover
Time perspective
Cross-sectional
Treatments tested in this trial
Stockholm3
Diagnostic testPredictive value of Stockholm3 test in a prostate cancer cohort on Active Surveillance (AS) for upgrading on re-biopsy
Treatment groups
350 Participants
are divided into 1 treatment groupGroup A: Stockolm3 Blood test in prostate cancer patient under active surviellance1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of the Stockholm3 test for detection of histological upgrading to ISUP Grade Group ≥2 at follow-up prostate biopsy
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).
Time frame
At time of follow-up biopsy (baseline visit; Day 0 of study procedures)Secondary outcomes
1
Sensitivity and specificity of the Stockholm3 test at predefined risk thresholds (≥11, ≥13, ≥15) for detection of ISUP Grade Group ≥2 prostate cancer
Diagnostic performance of the Stockholm3 test will be evaluated at predefined thresholds using contingency table analysis. Sensitivity, specificity, PPV, NPV, and AUC will be calculated to compare performance across thresholds.
Time frame
At time of follow-up biopsy (baseline visit)2
Comparative diagnostic accuracy of Stockholm3 test versus PSA density, PSA doubling time, and MRI progression for detection of ISUP Grade Group ≥2 upgrading
The predictive performance of Stockholm3 will be compared with PSA density (PSAd ≥0.15), PSA doubling time (\<3 years), and MRI progression (PRECISE classification ≥3 or ≥4). Diagnostic accuracy metrics (sensitivity, specificity, PPV, NPV, and AUC) will be calculated and compared between methods.
Time frame
At time of follow-up biopsy3
Change in patient-reported quality-of-life scores measured using the EPIC-26 questionnaire following prostate biopsy
Quality of life will be assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26). Domain scores (urinary, bowel, sexual, and hormonal function) will be summarized as mean change from baseline to 4 weeks post-biopsy. Clinically meaningful deterioration will be defined as a decrease of ≥10 points in domain score.
Time frame
Baseline and 30 days after prostate biopsySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: