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

Insel Gruppe AG, University Hospital Bern

Status: Not yet enrolling

Conditions: Active Surveillance for Prostate Cancer; Prostate Cancer

Treatments: Diagnostic Test: Stockholm3

Study type: Observational

Funder types: Other

Identifiers

NCT07478536

CHAS3-2025-NG-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

350 participants in 1 patient group

Stockolm3 Blood test in prostate cancer patient under active surviellance

Description:

Diagnostic procedure

Treatment:

Diagnostic Test: Stockholm3