A Single-arm, Multicenter Prospective Study to Evaluate the Diagnostic Performance of PROSTest in Men With PSA ≥ 3ng/ml Using Biopsy as the Sole Ground Truth

Brief summary (registry, in English)

This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology.

What you commit to

• Study type: Observational
• Planned participants: 1500
• From 15 Apr 2026 to the primary completion date, 28 Feb 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 45 years to 80 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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