Active Surveillance for Prostate Cancer, Prostate Cancer
Conditions
Keywords
Prostate, Cancer, Active Surveillance, Stockholm3, MRI, Biopsie
Brief 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.
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_TESTStockholm3
Predictive value of Stockholm3 test in a prostate cancer cohort on Active Surveillance (AS) for upgrading on re-biopsy
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of the Stockholm3 test at predefined risk thresholds (≥11, ≥13, ≥15) for detection of ISUP Grade Group ≥2 prostate cancer | At time of follow-up biopsy (baseline visit) | 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. |
| Comparative diagnostic accuracy of Stockholm3 test versus PSA density, PSA doubling time, and MRI progression for detection of ISUP Grade Group ≥2 upgrading | At time of follow-up biopsy | 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. |
| Change in patient-reported quality-of-life scores measured using the EPIC-26 questionnaire following prostate biopsy | Baseline and 30 days after 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. |
Countries
Switzerland
Contacts
CONTACTNicola Giudici, Dr.
CONTACTAnselm Lafita, CRC
STUDY_CHAIRBeat Roth, Prof. Dr. med.
Inselspital, University Hospital of Bern
Outcome results
None listed