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

University Hospital, Basel, Switzerland380 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

380

Conditions

Prostate Cancer Localized Carcinoma

Interventions

Stockholm3DIAGNOSTIC_TEST

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital Basel, Urology

Basel, Switzerland

Outcomes

Primary Outcomes

Cancer detection

Correlation between Stockholm3 and histological diagnosis of prostate cancer

Time frame: 2020-2022

Secondary Outcomes

Disease state

Correlation between Stockholm3 and clinical disease stage

Time frame: 2020-2022

Data from ClinicalTrials.gov

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