While urologists and radiation oncologists are increasingly turning to genetic testing for prostate cancer management, many are still relying on traditional tools like PSA and Gleason features alone. As of 2021, nearly three quarters of providers were not ordering genetic tests at the time of biopsy.^1,2,3 In separate findings published by the American Cancer Society, providers report that less than half of eligible patients receive these kinds of tests.⁴

The obstacles most cited for providers not ordering genetic tests is lab turn-around time, cost/coverage issues and tissue sample requirement.⁵ However, the benefits of ordering a genetic test for prostate cancer patients at biopsy provides unique insights into the aggressiveness of the disease, which helps to guide more informed decisions about treatment strategies that can be tailored to individual patient needs.

Once a provider decides to adopt genetic testing into their treatment decision pathways, they first must make a decision on the most effective test for the clinical questions most important at biopsy, of which there are a handful of tests recommended by national guidelines.

Selecting the right test for the right clinical question

“I don’t think men should look at these biomarkers as ‘which is best’ or a race to a finish line, but they should look at them as ‘which is the right tool for the question I am asking?‘” said Jonathan Tward, MD, Ph.D., of the University of Utah in a recent online interview.⁶

In selecting the appropriate genetic test for untreated prostate cancer patients, providers must align this tool with the clinical questions at hand such as determining suitability for active surveillance or assessing the potential futility of ADT in intermediate-risk prostate cancer patients.

Molecular biomarkers, like the Prolaris^® Prostate Cancer Prognostic Test, are important steps beyond clinical features alone because they provide personalized information about the aggressiveness of each patient’s prostate cancer. Prolaris specifically helps providers determine if patients are safe to forgo treatment, if they should pursue treatment, and how much treatment is needed for the best possible outcome.

Dr. Tward explains how he uses the Prolaris test in his practice.

Data published on other genomic tests demonstrate their ability for providing post-surgery prognostic information on metastasis risk. However, their guidance at the time of biopsy relies on data that is insufficient to directly inform treatment decisions such as active surveillance versus active treatment.

“The NCCN does indicate that Decipher has Level 1 evidence by Simon Criteria,” Tward explains later in the interview. “However, it is important to understand that performing post-hoc biomarker testing on patients enrolled in completed prospective trials (which is Level 1 evidence for the trial question) is different from saying that the trials were designed to test the biomarker itself for its performance.”

Genetic testing for active surveillance decisions

In contrast, Prolaris offers a tailored solution for assessing the suitability of active surveillance directly from biopsy tissue. Developed to specifically address the safety of active surveillance, Prolaris provides precise risk assessments of prostate cancer-related mortality, based on studies following cohorts of men on active surveillance. This evidence-driven approach ensures that the risk assessments provided by Prolaris support informed decision-making, offering clarity and confidence to patients and clinicians alike.

The Michigan Urological Surgery Improvement Collaborative compared Prolaris, GPS (formerly Oncotype) and Decipher on each biomarker’s ability to identify patients for active surveillance.

Genetic testing for treatment intensification decisions

An advantage of Prolaris lies in its ability to provide precise reports on the risk of metastasis for men with localized prostate cancer. Specifically, Prolaris helps to inform treatment decisions between monotherapy (such as radical prostatectomy or radiation therapy) and the potential risk reduction associated with intensified treatment, such as radiation combined with androgen deprivation therapy (ADT).⁷

By looking at the differences in metastasis outcomes between treatment modalities and risk of mortality for men on active surveillance, Prolaris offers clarity and guidance unmatched by other genomic classifiers in the prostate cancer space.

Dr. Christopher Lee, radiation oncologist at Cancer Care Northwest, explains how he uses the Prolaris report to navigate treatment decisions with his prostate cancer patients.

Expanding accessibility to genetic testing

As a leader in genetic testing and precision medicine, Myriad is dedicated to advancing health and well-being for all individuals, offering insights that empower patients and healthcare providers alike in detecting, treating, and preventing disease.

With a steadfast commitment to accessibility, Myriad provides patients access to accurate and affordable results through extensive coverage with most insurance plans and financial assistance programs. Medicare covers 100% of the cost of testing and 97% of privately insured patients pay $0.⁸

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References

1. GlobalData Biopsy Devices – United States 2015 – 2030
2. Internal Myriad Data
3. Clarify Health Claims Data 2021​
4. Survey findings summary: Understanding provider utilization of cancer biomarker testing across cancers. (2021). [Dataset]. In Cancer Action Network. American Cancer Society. https://www.fightcancer.org/sites/default/files/national_documents/provider_utilization_of_biomarker_testing_polling_memo_dec_2021.pdf
5. Survey findings summary: Understanding provider utilization of cancer biomarker testing across cancers. (2021). [Dataset]. In Cancer Action Network. American Cancer Society. https://www.fightcancer.org/sites/default/files/national_documents/provider_utilization_of_biomarker_testing_polling_memo_dec_2021.pdf
6. Wolinsky, H. (2024, March 21). Expert deep dives Decipher, Prolaris, GPS, Artera AI–tests to guide prostate cancer decisions. The Active Surveillor. https://howardwolinsky.substack.com/p/expert-deep-dives-in-decipher-prolaris
7. Myriad Genetics adds absolute risk reduction to prolaris Prostate Cancer Prognostic Test | Applied Radiation Oncology. (n.d.). https://www.appliedradiationoncology.com/articles/myriad-genetics-adds-absolute-risk-reduction-to-prolaris-prostate-cancer-prognostic-test
8. https://myriad.com/about-myriad-genetics/