Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 Trial)

NCT07478536 | Not Yet Recruiting

• 1 other identifier: CHAS3-2025-NG-001
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Active Surveillance for Prostate Cancer

Keywords

Prostate; Cancer; Active Surveillance; Stockholm3; MRI; Biopsie

Outcome Measures

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).

  At time of follow-up biopsy (baseline visit; Day 0 of study procedures)

Secondary Outcomes (3)

• 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)

• 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

• Change in patient-reported quality-of-life scores measured using the EPIC-26 questionnaire following prostate biopsy

  Baseline and 30 days after prostate biopsy

Study Arms (1)

Stockolm3 Blood test in prostate cancer patient under active surviellance

Diagnostic procedure

Diagnostic Test: Stockholm3

Interventions

Stockholm3 DIAGNOSTIC_TEST

Predictive value of Stockholm3 test in a prostate cancer cohort on Active Surveillance (AS) for upgrading on re-biopsy

Stockolm3 Blood test in prostate cancer patient under active surviellance

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male Patients with a prostate cancer diagnose under active surveillance being treated on Swiss Hospitals

You may qualify if:

• Adult Men ≥ 18 y. o.
• Men with low-risk prostate cancer (D'Amico risk classification) currently undergoing Active Surveillance (AS)
• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, University Hospital of Bern

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Beat Roth, Prof. Dr. med.

  Inselspital, University Hospital of Bern

  STUDY CHAIR

Central Study Contacts

Nicola Giudici, Dr.

CONTACT

+41316322332; urologie.studienmanagement@insel.ch

Anselm Lafita, CRC

CONTACT

+41316322332; anselm.lafita@insel.ch

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CH (1)