Oncotype DX Genomic Prostate Score

About the Oncotype DX Genomic Prostate Score Assay

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:

Clinical risk

  • 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

Tumor aggressiveness

  • 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 management4,5
  • 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

Androgen Signaling Cellular Organization Stromal Response Cellular Proliferation Reference
AZGP1
FAM13C
KLK2
SRD5A2
FLNC
GSN
GSTM2
TPM2
BGN
COL1A1
SFRP4
TPX2 ARF1
ATP5E
CLTC
GPS1
PGK1

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.2,6,7
  • Validated in two large, contemporary studies as a strong, independent predictor of adverse pathology at radical prostatectomy.2,3

Included within NCCN 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).

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.8,9

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.8
  • 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.9
  • 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.10

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 4,500 patients.3 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.

REFERENCES

1. Klein et al. Eur Urol. 2014.
2. Cullen et al. Eur Urol. 2014.
3. Van Den Eeden et al. Eur Urol. 2018.
4. Kozminski et al. Eur Oncol. 2016.
5. Eggener et al. J Urol. 2011.
6. Knezevic et l. SUO. 2013.
7. Data on file. Genomic Health, Inc.
8. Badani et al. Urol Pract. 2015.
9. Dall’Era et al. Urol Pract. 2015.
10. Canfield et al. Reviews in Urol. 2018.
11. Lynch et al. Am J Manage Care 2017.
12. Albala et al. Rev Urol. 2016.
13. Bonham et al. USCAP 2016.
14. Salmasi et al. J Urol. 2018.
15. Eure et al. Urology 2017.
16. Leapman et al. PloS One. 2017.

a. DOI: 10.3909/riu0786

b. DOI: 10.1016/j.eururo.2017.09.013

* Kaiser Permanente Northern California (KPNC) retrospective cohort study N=279 clinically low-, intermediate-, and high-risk patients; biopsy. This study estimated 10-year mortality and metastasis risk based on patients after radical prostatectomy.
†University of California, San Francisco (UCSF) prospective validation study: N=395 clinically low-risk patients; needle biopsy.
‡ Center for Prostate Disease Research (CPDR) prospective validation study: N=402 clinically low-risk patients; needle biopsy.

 

National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN. NCCN does not endorse any product or therapy.

Interactive
Report Viewer

Take an interactive tour of the Oncotype DX Genomic Prostate Score report.

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Expanded Medicare Coverage

The Oncotype DX Genomic Prostate Score test is now covered by Medicare for favorable intermediate risk prostate cancer.

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Clinical Utility Study:
Active Surveillance Usea

In a large clinical data set of nearly 9,000 low risk prostate cancer patients, GPS utilization revealed a significant increase in AS.

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Clinical Validation:
KPNCb

Kaiser Permanente of Northern California assessed the association between GPS and two hard endpoints: metastasis and prostate cancer death in a cohort of 279 men.

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