NCCN Reinforces Prolaris' Value in Predicting Prostate Cancer Outcomes
The NCCN has endorsed the Prolaris prostate cancer prognostic test, reinforcing its position as a critical tool in prostate cancer prognostication.
Conceptual image for viral etiology of prostate cancer: © Dr_Microbe - stock.adobe.com
The National Comprehensive Cancer Network (NCCN) reaffirmed the Prolaris prostate cancer prognostic test's value by maintaining its status as an “advanced tool” in the 2024 NCCN Prostate Cancer Guidelines.1
Prolaris is one of the few gene expression–based tests to be included with a Category 2A level of evidence. The test continues to be a key tool in the management of patients with prostate cancer, particularly in helping clinicians personalize treatment decisions based on a patient's cancer aggressiveness.
“The updated NCCN Prostate Cancer Guidelines continue to solidify Prolaris' market position,” said Paul J. Diaz, president and chief executive officer of Myriad Genetics, in a press release. “While there have been certain mischaracterizations regarding the updated guidelines leading to confusion, extensive published evidence shows that Prolaris is a clinically recognized and effective tool in managing patients with prostate cancer. We are confident that our highly engaged clinicians will continue to see the guidelines as an additional reason to incorporate Prolaris in treatment decisions.”
About the Prolaris Prostate Cancer Prognostic Test
Prolaris is a molecular diagnostic test that is designed to evaluate the aggressiveness of prostate cancer. This test aids allows clinicians to potentially avoid giving patients aggressive treatments and helps determine whether more intensive management is necessary. The test can also quantify the benefit of adding androgen deprivation therapy (ADT) to radiation therapy (RT).
The test also provides prognostic information that informs the decision-making process in prostate cancer care. With this, clinicians are able to address crucial questions like whether it is safe to avoid immediate treatment, what the appropriate treatment regimen is, and what the patient’s risk of disease progression or metastasis is, and how this impacts the patient's treatment.
Supporting Clinical Evidence
The inclusion of Prolaris in the NCCN guidelines is backed by over 25 published studies. These trials have demonstrated the test's clinical utility, and recent research has further reinforced the test’s accuracy in predicting clinical outcomes and its ability to personalize care for patients with prostate cancer.
First, in a prospective study published in JCO Precision Oncology, researchers validated the combined clinical cell-cycle risk (CCR) score generated by the Prolaris test as a predictor for early metastasis.2 The study included 554 male patients with localized prostate cancer. Here, a high CCR score was linked with an increased risk of metastasis within 3 years of diagnosis.
The findings also showed that men with a CCR score above the multimodal threshold had a significantly higher risk of metastasis vs patients below the threshold. When patients with elevated CCR scores received multimodal therapy, their 3-year metastasis risk was notably reduced compared with patients who were treated with single-modality therapies, showing the clinical utility of Prolaris in stratifying risk and guiding treatment decisions.
Additionally, the CCR score proved to be a more reliable predictor of early metastasis when compared with other commonly used biomarkers.
Another study highlighted the value of Prolaris in predicting the benefit of combining ADT with RT for male patients with localized prostate cancer.3 The retrospective cohort study included 56,485 patients who were tested with Prolaris, and found that the addition of ADT to RT significantly reduced the risk of metastasis. This was particularly true in patients with higher CCR scores.
Overall, the absolute risk reduction from ADT increased with higher CCR scores, suggesting again that Prolaris can help identify patients most likely to benefit from intensifying treatment with ADT.
“Prolaris is the only test developed in untreated patients and the only test with 2 clinically validated thresholds. With its active surveillance threshold, Prolaris identifies the most appropriate patients for active surveillance across all biomarkers,” said George Daneker, Jr. MD, president and chief clinical officer, oncology, Myriad Genetics, in a press release.1 “With its multimodal threshold, Prolaris can identify which patients may consider treatment intensification.”
REFERENCES
NCCN prostate cancer guidelines reinforce status of Myriad Genetics' prolaris® test as an 'advanced tool' recommended for prognostic assessment. News release. Myriad Genetics, Inc. December 9, 2024. Accessed December 9, 2024. https://investor.myriad.com/news-releases/news-release-detail/25756/
Hutten RJ, Odei B, Johnson SB, Tward JD. Validation of the Combined Clinical Cell-Cycle Risk Score to Prognosticate Early Prostate Cancer Metastasis From Biopsy Specimens and Comparison With Other Routinely Used Risk Classifiers. JCO Precis Oncol. 2024;8:e2300364. doi:10.1200/PO.23.00364
Tward JD, Lenz L, Gutin A, et al. Using the Cell-Cycle Risk Score to Predict the Benefit of Androgen-Deprivation Therapy Added to Radiation Therapy in Patients With Newly Diagnosed Prostate Cancer. JCO Precis Oncol. 2024;8:e2300722. doi:10.1200/PO.23.00722
