Diagnostic Tests

What Physicians Need to Know

Prolaris Test for Prostate Cancer Risk Assessment

 

Am Fam Physician. 2019 Sep 1;100(5):311-312.

Prolaris is a genomic test that analyzes changes in 46 genes in prostate biopsy tissue. It generates a risk score to help predict the likelihood of disease progression in men with localized prostate cancer. Prolaris is intended to guide the decision regarding active surveillance without surgery or radiation for low- or intermediate-grade cancers vs. active treatment with immediate surgery or radiation therapy. The National Comprehensive Cancer Network guidelines recommend that physicians consider this test for patients with low-risk and favorable intermediate-risk disease and at least a 10-year life expectancy.1

Accuracy

The risk of prostate cancer progression is currently evaluated based on the prostate-specific antigen (PSA) value, the Gleason score, and clinical factors. Examples of prediction models include the National Comprehensive Cancer Network risk group and a model that integrates clinical, PSA value, and biopsy data.24

Prolaris is intended to increase the accuracy of these risk models by adding genetic information, and it provides an estimate of prostate cancer–specific mortality risk and whether the patient's cancer is less aggressive, similarly aggressive, or more aggressive than other patients in the risk group based only on clinical factors.5 The genetic information alone is used to generate a 10-point score, although the final risk assessment incorporates clinical factors as well as the genetic information. After adjusting for clinical characteristics such as PSA value, Gleason score, age, and the extent of spread, every additional point in the 10-point score is associated with a doubling in the risk of disease progression, indicating that the genetic information provides additional risk stratification beyond the clinical factors alone.

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TestIndicationPopulationCost*

Prolaris test

Risk stratification in men with localized prostate cancer who may be candidates for active surveillance

Men diagnosed with localized prostate cancer

$3,400


*—Payment rate according to the 2017 Canadian health technology assessment.5

TestIndicationPopulationCost*

Prolaris test

Risk stratification in men with localized prostate cancer who may be candidates for active surveillance

Men diagnosed with localized prostate cancer

$3,400


*—Payment rate according to the 2017 Canadian health technology assessment.5

Benefit

The potential clinical benefit of Prolaris is that men could make a more informed, personalized decision regarding active surveillance vs.

Address correspondence to Mark H. Ebell, MD, MS, at ebell@uga.edu. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

References

show all references

1. National Comprehensive Cancer Network. Guidelines in oncology: prostate cancer. Version. 4. 2018. Accessed December 29, 2018. https://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf...

2. Rodrigues G, Warde P, Pickles T, et al. Pre-treatment risk stratification of prostate cancer patients: a critical review. Can Urol Assoc J. 2012;6(2):121–127.

3. Coley RY, Zeger SL, Mamawala M, et al. Prediction of the pathologic Gleason score to inform a personalized management program for prostate cancer. Eur Urol. 2017;72(1):135–141.

4. Huntley JH, Coley RY, Carter HB, et al. Clinical evaluation of an individualized risk prediction tool for men on active surveillance for prostate cancer. Urology. 2018;121:118–124.

5. Health Quality Ontario. Prolaris cell cycle progression test for localized prostate cancer: a health technology assessment. Ont Health Technol Assess Ser. 2017;17(6):1–75. Accessed July 18, 2019. http://www.hqontario.ca/Evidence-to-Improve-Care/Journal-Ontario-Health-Technology-Assessment-Series

6. Crawford 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;30(6):1025–1031.

7. Shore ND, 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;195(3):612–618.

This series is coordinated by Kenny Lin, MD, MPH, Deputy Editor.

 

 

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