Clinical Cancer Research: Development and Clinical Validation of an in situ Biopsy Based Multi-Marker: Assay for Risk Stratification in Prostate Cancer

In a study consisting of more than 650 patients with biopsy Gleason Scores of 3+3 and 3+4, ProMark successfully and independently separated ‘favorable' (surgical Gleason ≤ 3+4 and organ-confined disease) from ‘non-favorable’ (surgical Gleason ≥ and/or non-organ-confined diease) pathology, improving he prediction of aggressive cancer in men with biopsy Gleason Scores of 3+3 and 3+4.

 
  • Study Objective: Can ProMark improve prediction of aggressive cancer in men with biopsy Gleason Scores 3+3 and 3+4?
  • Endpoint: Separate ‘favorable’(surgical Gleason ≤3+4 and organ-confined disease) from ‘non-favorable’ (surgical Gleason ≥4+3 and/or non-organ-confined disease) pathology
  • Study population: patients with biopsy Gleason Scores 3+3 and 3+4 
  • Primary cohort: 381 patients with matched prostatectomy specimens
  • Validation cohort: 276 patients with matched prostatectomy specimens
  • Results: 
    • With a favorable biomarker risk score of <0.33, there was only a 10% chance of having non-favorable pathology.
    • Among patients with a risk score >0.80, the likelihood of having favorable pathology was less than 5%.

A ProMark Score transitions your patient from being a member of a population, to being an individual who has personalized information about his specific risk.



ProMark also provides individualized prognostic information that adds to current risk stratification systems, as exhibited using the NCCN classifications below:



Use proven data to make the right treatment decision for your patient.

View the full study.

  

             

             ProMark Overview
             About ProMark
             How it Works
             An 8-Protein Signature
             Clinical Validation
             Image Recognition Technology
             The ProMark Report
             ProMark Billing
             Sample Preparation

             
             How to Order
             Useful Resources
             New York State Testing