NCT05294627CompletedNot Applicable
Validation of the Prostate Cancer Biomarker Stockholm3 for Improved Disease Detection and Classification in the Swiss Population
University Hospital, Basel, Switzerland1 site in 1 country380 target enrollmentStarted: January 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- Cancer detection
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Cancer detection
Time Frame: 2020-2022
Correlation between Stockholm3 and histological diagnosis of prostate cancer
Secondary Outcomes
- Disease state(2020-2022)
Investigators
Study Sites (1)
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