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Validation of the Stockholm3 Test for Detection of Prostate Cancer in the Swiss Population

Validation of the Prostate Cancer Biomarker Stockholm3 for Improved Disease Detection and Classification in the Swiss Population

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05294627
Enrollment
380
Registered
2022-03-24
Start date
2020-01-01
Completion date
2023-10-01
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localized Carcinoma, Prostate Cancer

Brief summary

The purpose of this study is to collect blood samples to investigate the prognostic performance of the STHLM3 test in a population of Swiss and German men suspected of harbouring prostate cancer based on a combination of elevated PSA levels (e.g. \>2.5 ng/ml) and/or pathological digital rectal examination and/or MRI-findings.

Interventions

DIAGNOSTIC_TESTStockholm3

Stockholm3 test prior to prostate biopsy. Prostate biopsy is preformed irrespective of the Stockholm3 score.

Sponsors

Department of Urology, University Hospital Freiburg, Freiburg, Germany
CollaboratorUNKNOWN
Department of Urology, Kantonsspital Graubünden, Chur, Switzerland
CollaboratorUNKNOWN
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 99 Years

Inclusion criteria

* Planned prostate biopsy due to suspicion of prostate cancer (usually due to a combination of elevated PSA levels \[e.g. \>2.5 ng/ml\] and/or pathological digital rectal examination and/or MRI-findings) * Written informed consent by the participant

Exclusion criteria

* Severe anemia (Hb \<60g/l) * Previously already established diagnosis of prostate cancer.

Design outcomes

Primary

MeasureTime frameDescription
Cancer detection2020-2022Correlation between Stockholm3 and histological diagnosis of prostate cancer

Secondary

MeasureTime frameDescription
Disease state2020-2022Correlation between Stockholm3 and clinical disease stage

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026