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NCT Number: NCT07478536

Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 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.

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Key information

Conditions

Prostate Cancer Active Surveillance for Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Inselspital, University Hospital of Bern

Bern, Canton of Bern, 3010, Switzerland

Location contact

Lafita Anselm, CRC

CONTACT

[email protected]

+41316322332

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stockholm3

Diagnostic Test

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

Primary outcomes

  1. Diagnostic accuracy of the Stockholm3 test for detection of histological upgrading to ISUP Grade Group ≥2 at follow-up prostate biopsy

    Time frame: 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 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

    Time frame: 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.

  2. Comparative diagnostic accuracy of Stockholm3 test versus PSA density, PSA doubling time, and MRI progression for detection of ISUP Grade Group ≥2 upgrading

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anselm Lafita, CRC

CONTACT

[email protected]

+41316322332

Nicola Giudici, Dr.

CONTACT

[email protected]

+41316322332

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Multicenter Validation of the Stockholm3 Test on Men on Active Surveillance: the CHAS3-Trial

Acronym: CHAS3

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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