Prostate CancerCHAS3NCT07478536
Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 Trial)
An observational study of Prostate Cancer and Active Surveillance for Prostate Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Active Surveillance for Prostate Cancer
- What is being tested?
- Stockholm3
- How many people
- 350 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2026to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male Patients with a prostate cancer diagnose under active surveillance being treated on Swiss Hospitals
Who may be able to join
- 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
Who cannot join
- - 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Inselspital, University Hospital of Bern
Bern, Canton of Bern, 3010
Lafita Anselm, CRC, +41316322332, urologie.studienmanagement@insel.ch
About this study
Official title: Multicenter Validation of the Stockholm3 Test on Men on Active Surveillance: the 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.
Read the 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.
- Being tested
- Stockholm3
- Keywords
- Prostate, Cancer, Active Surveillance, Stockholm3, MRI, Biopsie
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stockholm3Diagnostic test
Predictive value of Stockholm3 test in a prostate cancer cohort on Active Surveillance (AS) for upgrading on re-biopsy
| Study group | Role | What they receive |
|---|---|---|
| Stockolm3 Blood test in prostate cancer patient under active surviellance | Diagnostic procedure Receives: Diagnostic Test: Stockholm3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 30 days after prostate biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beat Roth, Prof. Dr. med., Study chair, Inselspital, University Hospital of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478536
- Sponsor's protocol ID
- CHAS3-2026-NG-001
- Acronym
- CHAS3
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Validation of the Stockholm3 Test on Men on Active Surveillance: the CHAS3-Trial
- ClinicalTrials.gov ID
- NCT07478536
- Acronym / sponsor ID
- CHAS3 / CHAS3-2026-NG-001
- Keywords
- Prostate, Cancer, Active Surveillance, Stockholm3, MRI, Biopsie
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stockolm3 Blood test in prostate cancer patient under active surviellance | – | Diagnostic Test: Stockholm3Diagnostic procedure |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male Patients with a prostate cancer diagnose under active surveillance being treated on Swiss Hospitals
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- - Prior prostate cancer treatment (surgery, radiation, chemotherapy, hormonal therapy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stockholm3Predictive value of Stockholm3 test in a prostate cancer cohort on Active Surveillance (AS) for upgrading on re-biopsy | Diagnostic test | Stockolm3 Blood test in prostate cancer patient under active surviellance |
Primary outcome
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).
3 secondary outcomes
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)
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beat Roth, Prof. Dr. med. study chair
Inselspital, University Hospital of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Active Surveillance for Prostate Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Giudici, Dr. (+41316322332, urologie.studienmanagement@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.