Payer News
April 2020
 

ASCO issued evidence-based guidelines for molecular biomarkers in localized prostate cancer 

ASCO recently published its new guidelines, “Molecular Biomarkers in Localized Prostate Cancer” after a systematic literature review conducted by a multidisciplinary Expert Panel, with representatives from the European Association of Urology, American Urological Association, and the College of American Pathologists.1 The guidelines include recommendations regarding the clinical use and indications of certain prostate cancer biomarkers.

Who will benefit from active surveillance? Who has clinically significant prostate cancer?

Upon reviewing these two clinical questions, ASCO concluded that commercially available biomarkers improve risk stratification and guide patient management, endorsing their use.

ASCO recommends Prolaris®, because:

  • Prolaris determines if men have more or less aggressive disease than predicted by clinical features alone2
  • Prolaris identifies men with unfavorable intermediate-risk disease who are deciding whether to add androgen deprivation therapy to radiation therapy3,4
  • Decision-impact studies show Prolaris reduces unnecessary prostatectomies and radiation treatments, reducing overtreatment and associated morbidities5,6
  • Clinical utility studies show Prolaris confirms low-risk disease and increases active surveillance safely7,8
Societies support Prolaris 1,4,9-11
  • National Comprehensive Cancer Network® (NCCN) for men with low-, favorable intermediate-, unfavorable intermediate-, and high-risk disease
  • Medicare for men with very low-, low-, and favorable intermediate-risk disease
  • American Academy of Clinical Urologists (AACU)
  • Large Urology Group Practice Association (LUGPA)
  • Washington State Health Care Authority
  • American Society of Clinical Oncology (ASCO)

Learn more about Prolaris by viewing our  Insurance Providers webpages

References

1Eggener SE, et al. Molecular biomarkers in localized prostate cancer: ASCO guideline. J Clin Oncol 37, 2019.

2Lin DW, et al. Identification of men with low-risk biopsy-confirmed prostate cancer as candidates for active surveillance. Urologic Oncology 2018; 36(6): 310.e7-310.e13.

3Tward J, et al. Ability of the combined clinical-cell cycle risk score to identify patients who benefit from multi versus single modality therapy in NCCN intermediate- and high-risk prostate cancer. Scientific poster, ASCO-GU 2020.

4National Comprehensive Cancer Network® NCCN Clinical Guidelines in Oncology (NCCN Guidelines®) Prostate Cancer Version 1.2020. Available at www.nccn.org <accessed March 16, 2020>.

5Crawford ED, Scholz MC, Kar AJ, et al. Cell cycle progression score and treatment decisions in prostate cancer: results from an ongoing registry. Curr Med Res Opin 2014 Jun; 30(6):1025-31.

6Shore N, Kella N, Moran B, et al. Impact of the cell cycle progression test on physician and patient treatment selection for localized prostate cancer. J Urol 2016 March; 195:612-18.

7Hu JC, et al. Clinical utility of gene expression classifiers in men with newly diagnosed prostate cancer. JCO Precision Oncology 2018; 1-15.

8Kaul S, et al. Clinical outcomes in men with prostate cancer who selected active surveillance using a clinical cell-cycle risk score. Per Med 2019 Nov;16(6):491-9.

9MolDX: Prolaris Prostate Cancer Genomic Assay Final LCD - Effective October 15, 2015; Contractor Determination Number: L36350.; MolDX: Prolaris Prostate Cancer Genomic Assay Final LCD - Effective July 10, 2017; Contractor Determination Number: L37082.

10American Urological Association. Guideline for the management of clinically localized prostate cancer: 2017 Update. https://www.auanet. org/guidelines/prostate-cancer-clinically-localized-guideline <accessed January 7, 2020>.

11Washington State Health Care Authority. Health Technology Clinical Committee Findings and Decision: Gene expression profile testing of cancer tissue, May 2018.

Myriad, the Myriad logo, Prolaris and the Prolaris logo are either trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and other jurisdictions. ©2020 Myriad Genetic Laboratories, Inc.

     

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