Decipher prostate test receives high evidence rating in NCCN guidelines

The Decipher Prostate Genomic Classifier has received a Level 1B evidence rating, the highest rating among molecular tests, in the 2024 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology, according to a news release by Veracyte, the developer of the test.¹

The guidelines synthesize the published data on the Decipher test and describe the treatment implications for patients based on NCCN risk-group and Decipher score

The Decipher test is a 22-gene prognostic tool used for the risk stratification of patients with localized prostate cancer. The 1B evidence level was granted based on data on the test in the post-biopsy and post-prostatectomy settings. To determine their rating, the NCCN used “Simon Criteria,” which is published criteria for assigning a level of evidence for clinical biomarkers.

“We commend the NCCN panel for their evidence synthesis and expert consensus that has again designated the Decipher Prostate test as the gene expression tool for risk stratification supported by the most clinical evidence across the spectrum of the disease and has uniquely provided clinical guidance that integrates a patient’s Decipher score,” said Elai Davicioni, PhD, medical director of urology for Veracyte, in the news release.¹ “These recommendations reflect the extensive clinical evidence generated in collaboration with clinical trial groups from around the world from analysis of many thousands of their patients, including those from practice-changing phase 3 studies. Ultimately, we believe that these guidelines will help our customers better use the Decipher Prostate test and tumor biology to provide optimal care for more of their patients with prostate cancer.”

Data on the Decipher prostate test

The NCCN guidelines synthesize the published data on the Decipher test and describe the treatment implications for patients based on NCCN risk-group and Decipher score.²

In patients with NCCN low-risk prostate cancer and a Decipher score of 0.6 or higher, the guidelines reference a study demonstrating that GC high risk (≥0.6) was independently associated with a shorter time on active surveillance and shorter time to treatment failure (TTF) for those who underwent radical therapy.³ Thus, they recommend that more intensive active surveillance be considered in patients with NCCN low-risk disease and a high Decipher score.

For patients with NCCN intermediate-risk and a Decipher score lower than 0.45 of lower or 0.60 or higher, the guidelines recommend that radiotherapy alone should be considered, and the addition of short-term androgen deprivation therapy (ST-ADT) be considered in patients with a high Decipher score given their increased risk of distant metastasis (DM) and the benefit of ST-ADT on DM. Data from the study showed that patients with low Decipher scores receiving radiotherapy alone showed a 10-year DM of 4%, compared with 16% for Decipher high-risk. Overall, the NRG/RTOG 0126 study demonstrated the independent prognostic effect of Decipher score on biochemical failure, secondary therapy, DM, PCSM, metastasis-free survival, and overall survival.⁴

In patients with NCCN high-risk and a Decipher score of 0.45 of lower or 0.60 or higher, the guidelines compare radiotherapy plus long-term ADT (LT-ADT) and ST-ADT. Based on data from a meta-analysis of 3 phase 3 trials (NRG/RTOG 9202, 9413, and 9902), the guidelines recommend that radiotherapy plus LT-ADT be the option for most patients with NCCN high-risk disease, regardless of the Decipher score. However, the guidelines note that patients with Decipher low-risk should be counseled that a shorter duration of ADT may be reasonable given that the benefit of LT-ADT over ST-ADT is smaller for patients with a low-risk Decipher score (3%) compared with high-risk (11%) when accounting for age, comorbidities, and patient preference.⁵

Reference

1. Veracyte’s Decipher Prostate Test receives highest evidence-level rating among molecular tests in updated prostate cancer NCCN guidelines. News release. Veracyte Inc. February 27, 2024. Accessed February 28, 2024. https://investor.veracyte.com/news-releases/news-release-details/veracytes-decipher-prostate-test-receives-highest-evidence-level

2. NCCN guidelines: prostate cancer. https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1459

3. Vince RA, Jiang R, Qi J, et al. Impact of Decipher Biopsy testing on clinical outcomes in localized prostate cancer in a prospective statewide collaborative. Prostate Cancer Prostatic Dis. 2022;25(4):677-683. doi:10.1038/s41391-021-00428-y

4. Spratt DE, Liu VYT, Michalski J, et al. Genomic Classifier performance in intermediate-risk prostate cancer: results from NRG Oncology/RTOG 0126 randomized phase 3 trial. Int J Radiat Oncol Biol Phys. 2023;117(2):370-377. doi:10.1016/j.ijrobp.2023.04.010

5. Nguyen PL, Huang HCR, Spratt DE, et al. Analysis of a biopsy-based genomic classifier in high-risk prostate cancer: meta-analysis of the NRG Oncology/Radiation Therapy Oncology Group 9202, 9413, and 9902 phase 3 randomized trials. Int J Radiat Oncol Biol Phys. 2023;116(3):521-529. doi:10.1016/j.ijrobp.2022.12.035