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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294627
• Other study ID #: Stockholm3
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: October 1, 2023
• Est. primary completion date: November 1, 2022
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Stockholm3
Stockholm3 test prior to prostate biopsy. Prostate biopsy is preformed irrespective of the Stockholm3 score.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Urology	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Department of Urology, Kantonsspital Graubünden, Chur, Switzerland, Department of Urology, University Hospital Freiburg, Freiburg, Germany

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer detection	Correlation between Stockholm3 and histological diagnosis of prostate cancer	2020-2022
Secondary	Disease state	Correlation between Stockholm3 and clinical disease stage	2020-2022