PROSTest for Prostate Cancer Diagnosis
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
- Age
- 45 – 80
- Sex
- Male
- Study type
- Observational
- Participants needed
- 1,500 (estimated)
- Sponsor
- Wren Laboratories LLC · Industry
This trial is looking for men who have high PSA levels or abnormal prostate exams and are referred for a prostate biopsy. Participants will have a blood sample taken before the biopsy to test with PROSTest, and the results will be compared to the biopsy findings.
You may be able to join if
- I have elevated PSA levels
- I have an abnormal digital rectal examination
You may not be able to join if
- I have been diagnosed with prostate cancer before
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your EligibilityThis 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.
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