The Oncotype DX Genomic Prostate Score (GPS) assay is the only genomic assay designed for men with clinically low-risk or favorable intermediate-risk cancer to help make treatment decisions at the time of diagnosis. The assay analyzes prostate cancer gene activity to predict disease aggressiveness.
It examines interactions among genes in the tumor to better understand the unique biology of the cancer—a science known as genomics—for prostate cancer patients. Essentially, the Oncotype DX GPS assay provides more specific and individualized information about prostate cancer aggressiveness based on the biology of the tumor. The assay:
- Provides a GPS result ranging from 0-100 that corresponds to the biologic aggressiveness of the tumor.
- Measures biology through the expression of 17 genes across four important genetic pathways and, in conjunction with clinical risk factors, predicts the likelihood of adverse pathology, prostate cancer death, and metastasis at 10 years1*.
Leverage adverse pathology to assess tumor aggressiveness and inform immediate treatment decisions1,2
Adverse pathology is the presence of high-grade (Gleason Score >4 + 3) and/or non-organ-confined disease (pT3+). It provides an immediate snapshot of the risk of aggressive disease at the time of biopsy.
Biopsy alone often misses patients with high risk of adverse pathology.
Predicts BOTH clinical risk and tumor aggressiveness
The Oncotype DX Genomic Prostate Score test provides a comprehensive risk profile for personalized information to guide treatment decisions.
Oncotype DX GPS assay is proven to be an independent predictor of:
- Prospectively validated as an independent predictor of both prostate cancer death and metastasis at 10 years3*
- Predicts future tumor behavior and helps patients understand long-term prognosis to ease patient concerns and offer reassurance3
- Prospectively validated as an independent predictor of adverse pathology (Gleason >4+3 and/or pT3a+),2,3† the most important and actionable endpoint when individualizing patient management
- Identifies patients with less aggressive disease who are likely candidates for Active Surveillance
- Helps guide use of more aggressive treatment for patients with more aggressive disease
Multiple biologic pathways were more predictive than any single pathway alone2
Learn more about Oncotype DX GPS assay development studies
The GPS assay was:
- Developed based on multiple collaborative studies with the Cleveland Clinic, UCSF, and other centers to specifically address the many challenges inherent in prostate cancer risk assessment.2,6
- Validated in two large, contemporary studies as a strong, independent predictor of adverse pathology at radical prostatectomy.2,3
Included within guidelines
NCCN Guidelines include the GPS assay as a Category 2A molecular testing option for consideration in prostate cancer patients with clinically low-risk and favorable intermediate-risk disease (life expectancy >10 years).
ASCO’s expert panel endorses tissue-based biomarkers, including Oncotype DX Prostate, to be used as part of the patient’s overall testing strategy when trying to decide between Active Surveillance and immediate treatment.
See the benefits of integrating the test into your practice
The Oncotype DX GPS reveals the underlying tumor biology in clinically low-risk patients to provide actionable information for treatment or management planning.
Efficient treatment planning
The Oncotype DX GPS assay provides refined risk stratification, allowing you to more confidently recommend active surveillance or immediate treatment. It has been demonstrated in three clinical utility studies to impact clinically meaningful changes in treatment planning across all clinically low-risk groups.7,8
Three clinical utility studies demonstrate how the Oncotype DX GPS test helps with treatment planning:
- A prospective study assessed changes in urologists’ treatment recommendations pre- and post-Oncotype DX GPS results. This decision-impact study demonstrated a 26% absolute change in management recommendations. Physician confidence improved in 85% of cases.7
- A retrospective study that compared 6-month management received in clinically low-risk patients with and without the Oncotype DX GPS results. This chart-review analysis revealed a 56% relative increase in the number of patients on active surveillance/watchful waiting at 6 months post-diagnosis when GPS testing was added to standard decision making tools.8
- A retrospective study of a large clinical data set of 8,920 patients compared of active surveillance treatment rates among four early prostate cancer cohorts: 1) patients who had Oncotype DX GPS tests, 2) patients who had MRI, 3) patients who received both GPS tests and MRI, and 4) patients who had neither. GPS testing was associated with significantly increased utilization of active surveillance.9
Explaining risk to patients
The Oncotype DX GPS assay provides meaningful information on the aggressiveness of the tumor that, when combined with clinical pathologic features (PSA levels, Gleason score, anatomic stage, and NCCN® risk classification), helps when discussing management options with patients. The GPS report is a patient-friendly resource that facilitates discussions by consolidating key prostate cancer characteristics in a single document for ease of reference during management conversations.
Clear advantages for your patients
The Oncotype DX GPS assay has been developed and studied in over 5,300 patients.1-15 The results from the assay refine risk assessment, help guide treatment decisions, and potentially impact patient quality of life. For example, the results might give a low- or favorable intermediate-risk patient the additional confidence he needs to pursue active surveillance, delaying or even completely avoiding the side effects of more aggressive treatment options like prostatectomy or radiation therapy.