Investigational Assay Shows Promise as Prognostic Tool for Prostate Cancer

3D illustration of a tumor in the prostate gland: ©Dr_Microbe - stock. adobe.com

New data supports the use of the Decipher Prostate Genomic Classifier to help physicians make better treatment predictions and decisions for patients with prostate cancer. Investigators presented the data at the American Society for Radiation Oncology (ASTRO) Annual Meeting in San Diego, California.

“This study reinforces the ability of the [Decipher Prostate Genomic Classifier] to improve risk stratification in high-risk prostate cancer, and thereby support more informed, personalized treatment decisions for these patients,” said Phuoc T. Tran, MD, PhD professor and vice chair for research of radiation oncology at the University of Maryland School of Medicine, and co-senior investigator for the study.¹

The Decipher Prostate Genomic Classifier is a 22-gene, whole-transcriptome-developed test. It can help inform treatment decision for patients with localized prostate cancer at diagnosis and after surgical removal. The patient’s Decipher score prognosticates a patient’s risk of metastasis within 5 years.² The score ranges from 1 to 1.0, and a score of 0.45 or lower indicates a lower risk of metastasis and death from prostate cancer, while a score of 0.60 indicates a higher risk.³

In one study (NCT00288080) investigators tested the prognostic performance of the assay in high-risk patients with localized prostate cancer from the phase 3 NRG RTOG 051 trial (NCT01872975). Patients received radiation and 2 years of androgen deprivation therapy with or without docetaxel chemotherapy. Investigators obtained biopsies from 183 patients and generated test scores, and patients were followed for a median of 9.9 years.

The results showed that only the Decipher risk score was independently associated with metastasis-free survival (MFS) (HR, 1.12; 95% CI) and distant metastasis (DM; sHR, 1.22; 95% CI) compared to standard risk factors like Gleason score, T-stage, and prostate-specific androgen level. Patients with higher risk Decipher scores had worse DM (sHR, 2.2; 95% CI) compared to those with low-risk scores. Cumulative DM after 10 years was 27% for patients with high-risk scores vs 9% for low-risk scores (95% CI).

“The findings presented at ASTRO 2023 add to the large body of evidence, which now includes 12 phase 3 randomized trials, demonstrating the Decipher Prostate classifier’s performance as a tool to help guide therapeutic decisions in prostate cancer,” Elai Davicioni, PhD, medical director of urology at Veracyte, Decipher’s manufacturer, said in a press release. “Furthermore, they reinforce that the substantial level of evidence supporting the Decipher Prostate test can help guide its selection and utilization for patients with prostate cancer.”¹

An area of further research is testing the accuracy of Decipher Prostate Genomic Classifier in more people of color. An active validation study (NCT02723734) is evaluating the accuracy of the test between Black and White patients. The study has an estimated completion date of July 2024.⁴

REFERENCES

1. New data from phase 3 trial further validate prognostic value of Veracyte’s Decipher Prostate genomic classifier. Press release. October 4, 2023. Accessed October 6, 2023. https://tinyurl.com/4esrchc8

2. Decipher® Prostate Genomic Classifier. Veracyte. https://tinyurl.com/2p84kr3s

3. Jaber, Nadia. Hormone therapy for prostate cancer? A genetic test could help decide. National Cancer Institute. March 15, 2021. Accessed October 6, 2023. https://tinyurl.com/yc74vxcr

4. Validation study on the impact of Decipher® testing – VANDAAM study (VANDAAM). ClinicalTrials.gov. Updated August 3, 2023. Accessed October 6, 2023. https://tinyurl.com/2p9hz9ph