PROSTest test in men with elevated PSA to aid prostate cancer decisions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter study enrolls men referred for prostate biopsy due to elevated PSA or abnormal exam, with or without pre-biopsy MRI. Blood is collected before biopsy for PROSTest analysis, and biopsy pathology serves as the ground truth. PROSTest results are analyzed blinded to pathology, and diagnostic performance metrics like sensitivity, specificity, and AUC will be reported. Additional analyses will examine how PROSTest scores relate to MRI findings and Gleason grade group, and whether PROSTest could reduce unnecessary biopsies through decision-curve analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* elevated PSA and/or abnormal digital rectal examination

Exclusion Criteria:

* Previous Prostate cancer diagnosis

Where it's running

• Wren Laboratories
  Branford, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Mark Kidd, PhD
• Email: mkidd@wrenlaboratories.com
• Phone: 2038241128

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.