NCCN reaffirms Prolaris’ prognostic value in prostate cancer

The National Comprehensive Cancer Center (NCCN) has reclassified the Prolaris prostate cancer test as an “Advanced Tool” in the 2024 NCCN Prostate Cancer Guidelines, reinforcing the prognostic value of the test for prostate cancer assessment.¹

The inclusion of the test in the guidelines is supported by category 2A level of evidence.

As in past years, the inclusion of the molecular diagnostic test in the guidelines is supported by category 2A level of evidence. According to a news release from Myriad, this means that “its inclusion has support from at least 85% of members on the NCCN prostate panel.”

“The updated NCCN Prostate Cancer Guidelines continue to solidify Prolaris' market position,” said Paul J. Diaz, president and CEO of Myriad Genetics, in the news release.¹ “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.”

The inclusion of the test is supported by more than 25 studies demonstrating its clinical utility, including 2 studies published earlier this year.

The first study validated the combined cell-cycle risk (CCR) score generated by the Prolaris test for estimating risk of early metastasis and demonstrated the clinical utility of the CCR active surveillance and multimodality thresholds.²

Data showed that the CCR score was prognostic for 3-year metastasis (HR, 2.32; 95% CI, 1.17 to 4.59; P = .02), outperforming other validated biomarkers. Overall, the area under the curve for the risk of 3-year metastasis using the CCR score was 0.736.

Patients who had scores above the multimodality threshold had a higher risk for metastasis than those who scored below the threshold (HR, 5.44; 95% CI, 2.72 to 10.91; P < .001). Among those patients who scored above the threshold, the 3-year risk of metastasis was 3% for those who received multimodality therapy vs 14% for those who received single-modality therapy.

Patients who had a CCR score above the active surveillance threshold also demonstrated a faster time to first definitive treatment compared with those who scored below the threshold.

In total, the single-institution, prospective cohort study included 554 men with localized prostate cancer. All patients had available CCR scores from biopsy.

The second study showed that the CCR score could accurately determine when treatment intensification may be appropriate in men with localized prostate cancer.³ The study assessed 467 men who received Prolaris testing and were treated with radiotherapy alone. Based on data from a meta-analysis of trials, the relative benefit of adding androgen deprivation therapy (ADT) to reduce distant metastasis was estimated to be 41%.

Additionally, “The [absolute risk reduction] ARR and number needed to treat (NNT) were computationally derived in patients clinically tested with Prolaris between January 1, 2020, and October 31, 2022 (N = 56,485).”

Overall, investigators found that higher CCR scores correlated with a greater benefit of ADT to radiation therapy. Specifically, data showed an ARR from ADT of nearly 0 among those with low CCR scores, which increased to 17.1% among those with a CCR score of 3.690 and an NNT of 6. According to the authors, the NNT “indicat[es] that adding ADT to [radiation therapy] would prevent metastasis within 10 years for 1 of every 6 treated individuals.”

Using a CCR score of 2.112 as the multimodal treatment threshold, the average ARR was 0.86% among those who scored below the threshold (NNT = 116) and 8.19% among those who scored above the threshold (NNT = 12).

“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 of Oncology at Myriad Genetics, in the news release.¹ “With its multimodal threshold, Prolaris can identify which patients may consider treatment intensification.”

References

1. 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 18, 2024. https://www.globenewswire.com/news-release/2024/12/09/2993710/15459/en/NCCN-Prostate-Cancer-Guidelines-Reinforce-Status-of-Myriad-Genetics-Prolaris-Test-as-an-Advanced-Tool-Recommended-for-Prognostic-Assessment.html

2. 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 Feb:8:e2300364. doi:10.1200/PO.23.00364

3. 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