Prolaris^®:Personalizing Prostate Cancer Treatment

Addressing Pressing Questions about Prostate Cancer

One in seven men will be diagnosed with prostate cancer sometime in his lifetime and it is the most commonly diagnosed type of cancer among men in the U.S.¹

Getting a diagnosis of prostate cancer can be overwhelming for patients and their families. For most patients, a cancer diagnosis comes with a long list of pressing questions: Am I going to live? What about my family? How will this change the way I live my life? What treatment is right for me?

Diagnosis is just the first step on a prostate cancer path that can become a lifelong journey. Getting answers to pressing questions about prostate cancer can help patients and their families – as well as their doctors – manage the disease and move forward with confidence.

Talking to other patients who are living with prostate cancer and hearing about their journeys can be informative for those who have questions about the disease or its treatment. 

Getting Answers

Prostate cancer is a complex, highly variable disease. Although it is often nonaggressive, 10-15 percent of men with prostate cancer have aggressive, life-threatening tumors.² When it comes to making personalized decisions about prostate cancer management, the most pressing question for patients and doctors may be how aggressive is a specific patient’s tumor?

Traditional measures for assessing prostate cancer risk don’t provide all the information needed to appropriately determine treatment options. Clinical tests such as Gleason score and prostate-specific antigen (PSA) serve as standard measurements for prostate cancer severity but do not measure how aggressive the prostate cancer is or predict outcomes such as cancer-specific death and recurrence.

Prolaris^® Can Help

Prolaris is a prognostic test developed to assess the aggressiveness of prostate cancer by measuring the intensity of tumor cell proliferation in prostate tissue.

The Prolaris test from Myriad Genetics gives you a personalized risk assessment of your patients’ prostate cancer. Prolaris gives you the complete picture on how your patient’s prostate cancer will progress by adding clinically proven information in combination with traditional diagnostic tools – like PSA and Gleason, to avoid guesswork and create a truly informed and individualized treatment plan.

Prolaris has been shown to be the single most clinically significant prognostic parameter of outcomes at the time of diagnosis. The test provides unique additional information that can be combined with standard clinical factors to make the most accurate prediction of a patient’s prostate cancer aggressiveness Prolaris has been extensively validated across multiple patient cohorts in both pre- and post-treatment scenarios

Prolaris is now included in the National Comprehensive Cancer Network (NCCN) guidelines for all appropriate patients with localized prostate cancer.³ 

In August 2015, Medicare approved coverage of Prolaris for patients with low-risk and very low-risk prostate cancer (as defined by the NCCN). The Medicare decision extends coverage for testing to the approximately 60,000 patients with localized prostate cancer in the United States who meet the low-risk and very low-risk criteria.

Data have shown that:

• Prolaris accurately differentiates , with threshold, newly diagnosed patients who are more likely to die from prostate cancer within 10 years from those with lower-risk disease.⁴
• Prolaris accurately differentiates newly diagnosed patients, who are more likely to benefit from single or multi-treatment modality with a validated threshold.
• Prolaris accurately predicts biochemical recurrence and progression to metastatic disease following radical prostate surgery.⁵
• In 48% of cases, treatment plans for men with prostate cancer changed based on results from the Prolaris test.⁶
• Prolaris could save the U.S.A. healthcare system $6 billion over 10 years.⁷

Prolaris Clarifies Cancer Risk

One major attribute of cancer is that the affected cancer cells grow at an accelerated rate. The genes that provide information on the rate of cancer cell growth are called Cell Cycle Proliferation Genes (CCP). The Prolaris test looks at the CCP genes in the cancer to determine how aggressive the cancer is. The tumor aggressiveness score, also known as the Prolaris score, gives you biological clarity on how your patient’s tumor is behaving, thus helping your treatment plan to be specific and individualized for each patient.

Every Man with Prostate Cancer

DESERVES A BETTER ANSWER

Not all biomarker tests are the same. When it comes to making active surveillance or definitive treatment decisions, selecting the correct biomarker test matters. The Prolaris® test from Myriad Genetics is the only biomarker test on the market with both an Active Surveillance Threshold and a Multi-Treatment Modality Threshold.

Endopoints Matter when Selecting a Biomarker

It is critical to understand what information you are getting when selecting a biomarker. The Prolaris test looks at the disease endpoints that matter most and has been rigorously studied and proven to meet ALL of its primary endpoints.

Prolaris Endopoints:

10-year disease-specific mortality when considering conservative management

10-year risk of developing metastasis when considering definitive treatment

Other biomarker tests, like Oncotype DX and Decipher look at endpoints like adverse pathology. A recent independent study by Memorial Sloan Kettering called into question the use of adverse pathology for treatment recommendations for low-risk men. In a head-to-head study comparing Prolaris to adverse pathology, Prolaris was found to be 2.5 times better at predicting disease outcomes.

Prolaris Provides Peace of Mind

Prolaris supported by NCCN guidelines as a 2A recommendation which are all considered standard of care. Furthermore, the Prolaris test is the ONLY test with a validated Active Surveillance Threshold in untreated patients³; giving both patients and providers confidence with their treatment decisions.

Please contact us to inform and assist you for a reimbursement claim from your private medical insurance company.

PUBLICATIONS & MEDICAL POSTERS

In case you are looking for a detailed scientific publication on PROLARIS, please visit  -> https://prolaris.com/posters-and-medical-publications/#!#home

UNDERSTANDING THE PROLARIS REPORT

For a detailed explanation on revolutionary PROLARIS report, please visit -> https://prolaris.com/understanding-the-prolaris-report/

PROLARIS CASE STUDIES

You can visit ->  https://prolaris.com/prolaris-case-studies/ for detailed PROLARIS case studies.

PROLARIS test results are available in 2 weeks and the test performed to Myriad Genetics Laboratories, Salt Lake City, UTAH, USA

Either you are a physician or patient and you are interested to find more detailed information on PROLARIS please contact us or visit www.prolaris.com

REFERENCES

1. American Cancer Society. Prostate cancer. Available athttp://www.cancer/org/acs/groups/cid/documents/webcontent/003134-pdf.pdf.
2. Harvard School of Public Health. The prostate cancer predicament. Available athttp://www.hsph.harvard.edu/news/magazine/the-prostate-cancer-predicament/.
3. Myriad Genetics. Myriad announces inclusion of Prolaris test in NCCN guidelines. Available athttps://www.myriad.com/investors/press-release-detail/?newsItemId=878212.
4. Cuzick J, et al. Validation of a 46-gene cell cycle progression (CCP) RNA signature for predicting prostate cancer death in a conservatively managed watchful waiting needle biopsy cohort. American Urological Association Annual Meeting, May 20, 2014, Orlando, FL.
5. Bishoff JT, et al. Prognostic utility of the cell cycle progression score generated from biopsy in men treated with prostatectomy. The Journal of Urology 2014; 10.1016/j.juro.2014.02.003.
6. Shore N, et al. Clinical Utility of CCP Test in Personalizing Prostate Cancer Treatment. Presented at American Urological Association Meeting, May 17, 2015. Available athttps://myriad-web.s3.amazonaws.com/myriad.com/media-kits/Clinical%20Utility%20of%20CCP%20Test%20in%20Personalizing%20Prostate%20Cancer%20Treatment.pdf.
7. Crawford ED, et al. Evaluation of the economic impact of the CCP assay in localized prostate cancer. 2014 Society of Urologic Oncology, December 3, 2014, Rockville, MD
8. 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; 1-7
9. Shore, N D., et al. Impact of the cell cycle progression test of physician and patient treatment selection for localized prostate cancer. The Journal of Urology 2016;195(3),612- 618
10. Lin, D. W., et al. Identification of men with low-risk biopsy-confirmed prostate cancer as candidates for active surveillance. Urologic Oncology: Seminars and Original Investigations. 2018; doi: 10.1016/j.urolonc.2018.03.011.
11. Cuzick, J et al. Validation of an RNA cell cycle progression signature for prostate cancer death in a conservatively managed needle biopsy cohort. Br J Cancer. 113(3):382-9, 2015
12. Cuzick, J et al. Prognostic value of a cell cycle progression signature for prostate cancer death in a conservatively managed needle biopsy cohort. Br J Cancer. 106(6):1095-9, 2012
13. Data on file. Myriad Genetics Inc.

SCIENTIFIC PUBLICATIONS

For a fully and update scientific publications summary regarding PROLARIS® please visit -> https://prolaris.com/posters-and-medical-publications/#!#home