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

Completed

• Conditions: Localized Carcinoma; Prostate Cancer

• Registration Number: NCT05294627
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-03-24
• Primary Completion: 2022-11-01
• Study Completion: 2023-10-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 380

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cancer detection	2020-2022	Correlation between Stockholm3 and histological diagnosis of prostate cancer

Secondary Outcome Measures

Name	Time	Method
Disease state	2020-2022	Correlation between Stockholm3 and clinical disease stage

Trial Locations

Locations (1)

University Hospital Basel, Urology; 🇨🇭 Basel, Switzerland