Clinical Evidence

Developed, clinically validated, and studied in over 9,000 patients1-19


The Oncotype DX GPS test was specifically designed to guide treatment decisions in patients with clinically low- or intermediate-risk prostate cancer. Over 9,000 patients have been included in development studies, clinical validation studies, and clinical utility studies.1-19

Clinical validation studies

The clinical validation studies for the Oncotype DX Genomic Prostate Score (GPS) test were prospectively designed studies of archival tissue from a large, diverse set of data sources:

  • 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)20 provided more precise estimates for likelihood of adverse pathology.

20-Year outcomes21-22

A 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.21

In a large cohort of men with largely clinically low risk prostate cancer treated with radical prostatectomy, the study suggests the presence of adverse surgical pathology significantly predicted 20-year risk of metastasis and prostate cancer specific mortality. Patients with adverse pathology at radical prostatectomy had a twelve-fold higher risk of metastasis than those with favorable pathology, demonstrating the value of this endpoint for assessing risk in this population.22

  1. Van Den Eeden et al. Eur Urol. 2018.
  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 2017.
  9. Salmasi et al. J Urol. 2018.
  10. Eure et al. Urology 2017.
  11. Leapman et al. PloS One. 2017.
  12. Magi-Galluzzi​ et al. Urology. 2018.
  13. Eggener et al. Urology. 2019.
  14. Kornberg et al. J Urol. 2019a.
  15. Kornberg et al. J Urol. 2019b.
  16. Lin et al. J Clin. Onc. 2020.
  17. Moschovas et al. Eur Urol Focus. 2021.
  18. Aboushwareb et al. AUA annual meeting. 2021.
  19. Murphy et al. Urology. 2020.
  20. Brand et al. Urology. 2016.
  21. Brooks et al. JCO. 2021.
  22. Brooks et al. Urologic Oncology: Seminars and Original Investigations. 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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