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.
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.
Study Type
OBSERVATIONAL
Enrollment
350
Predictive value of Stockholm3 test in a prostate cancer cohort on Active Surveillance (AS) for upgrading on re-biopsy
Inselspital, University Hospital of Bern
Bern, Canton of Bern, Switzerland
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)
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)
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 biopsy
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.
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Time frame: Baseline and 30 days after prostate biopsy