"Biochemical recurrence following surgery identifies men for whom the surgery was not curative. Understanding a patient's individual risk for developing biochemical recurrence after treatment helps physicians and patients make well-informed treatment decisions," said Stephen Van Den Eeden, Ph.D., Kaiser Permanente Division of Research. "Our study revealed a strong association between the GPS result and biochemical recurrence that remained significant in multivariable analysis, thus demonstrating that Oncotype DX adds additional value to existing clinical criteria."

Additional data from the clinical validation study with Kaiser Permanente, including results of the analysis of the performance of the GPS in predicting the development of metastasis and prostate cancer death in patients with early-stage disease, have been accepted for presentation at future major urological meetings.


Prospective Study Demonstrates Oncotype DX GPS Is an Independent Predictor of High-risk Surgical Pathology (HRSP) in Men with Clinically Low-risk Disease

In previous retrospective cohorts, the GPS was validated as a predictor of adverse pathology and BCR in prostate cancer patients treated surgically with radical prostatectomy. In this new ongoing prospective observational study, conducted in a real-world, community healthcare setting, researchers analyzed the association between the GPS and HRSP in 122 men who elected to receive radical prostatectomy for initial disease management.

Results showed that the GPS was a significant, independent predictor of HRSP (p=0.018) across very low-, low- and intermediate-risk patients. The GPS remained significant after adjusting for NCCN risk group. These findings suggest that the test may be valuable in treatment planning for men with clinically low-risk prostate cancer who are at risk for HRSP and may need to consider adjuvant therapy after surgery.

Large Study Demonstrates that Medical Conditions Common in Prostate Cancer Patients Do Not Influence the Oncotype DX GPS

Validated molecular biomarkers can improve risk stratification in newly diagnosed patients with prostate cancer, but it is important to understand if biomarkers are influenced by common coexisting clinical conditions. Using data from the Center for Prostate Disease Research, researchers explored the association between the GPS and comorbidities – including obesity, diabetes mellitus, hypertension, hypercholesterolemia, coronary artery disease and low testosterone – in a cohort of 389 surgically treated men with clinically low-risk prostate cancer.

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