Clinical Evidence

Developed, clinically validated, and studied in over 5,000 patients1-15



>5,000
Patients1-15

The Oncotype DX GPS test was specifically designed to guide treatment decisions in patients with clinically low- or intermediate-risk prostate cancer. Over 5,000 patients have been included in development studies, clinical validation studies, and clinical utility studies.1-15

Clinical validation studies

The clinical validation studies for the Oncotype DX Genomic Prostate Score (GPS) test were conducted in a prospective fashion (using retrospective cohorts) from large, contemporary databases:

  • Kaiser Permanente, Northern California (KPNC) (N=259).1
  • University of California, San Francisco (UCSF) (N=395).2
  • Center for Prostate Disease Research (CPDR) (N=402).3

A meta-analysis combining the UCSF and CPDR cohorts (N=732)9 validated the association between the Oncotype DX GPS test and refined estimation of the likelihood of adverse pathology.

20-Year outcomes16

Study suggests that the Oncotype DX GPS assay may be prognostic for both distant metastasis and prostate cancer-specific mortality through 20 years after diagnosis, and that the GPS assay together with clinical factors may improve risk assessment over clinical factors alone.16

REFERENCES

  1. Van Den Eeden et al. Eur Urol. 2017.
  2. Klein et al. Eur Urol. 2014.
  3. Cullen et al. Eur Urol. 2015.
  4. Badani et al. Urol Pract. 2015.
  5. Albala et al. Rev Urol. 2016.
  6. Dall’Era et al. Urol Pract. 2015.
  7. Knezevic et al. BMC Genomics. 2013.
  8. Lynch et al. Am J Manage Care 2018.
  9. Brand et al. Urology. 2016.
  10. Bonham et al. USCAP 2016.
  11. Salmasi et al. J Urol. 2018.
  12. Eure et al. Urology 2017.
  13. Eure et al. AUA 2017.
  14. Leapman et al. PloS One. 2017.
  15. Cullen et al. Urology. 2020.
  16. Brooks et al. JCO. 2021.

a. DOI: 10.1016/j.urology.2018.11.050
b. DOI: 10.3909/riu0786
c. DOI: 10.1200/JCO.2016.34.15_suppl.e16611

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