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Completed

NCT Number: NCT05294627

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Localized Carcinoma Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–99 year

Sex eligibility

Male

Study type

Observational

Primary location

University Hospital Basel, Urology

Basel, 4031, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stockholm3

Diagnostic Test

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

Primary outcomes

  1. Cancer detection

    Time frame: 2020-2022

    Correlation between Stockholm3 and histological diagnosis of prostate cancer

Secondary outcomes

  1. Disease state

    Time frame: 2020-2022

    Correlation between Stockholm3 and clinical disease stage

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Department of Urology, Kantonsspital Graubünden, Chur, Switzerland
  • Department of Urology, University Hospital Freiburg, Freiburg, Germany

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 24, 2022
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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