Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, and University College London (UCL) today announced that data published online in Cell show that the Decipher Prostate Genomic Classifier predicts which patients with metastatic cancer are likely to benefit from treatment intensification with the chemotherapy docetaxel and which are not likely to benefit and can therefore avoid unnecessary toxicity. The findings—from the randomized, prospective, Phase 3 STAMPEDE trial—are the first to be published showing that a gene expression test can help clinicians better personalize chemotherapy decisions for patients with metastatic prostate cancer.
Globally, nearly 1.5 million new cases of prostate cancer are diagnosed each year and the disease accounts for a fifth (nearly 400,000) of all cancer-related deaths in men, with these numbers expected to increase over the next two decades.1,2 In the United States, nearly 315,000 patients will be diagnosed with prostate cancer this year and it is the second-leading cause of cancer deaths among men. Most prostate cancer deaths occur in patients who first presented with advanced or metastatic disease—a group that has been growing faster in recent years in the U.S., compared to those presenting with localized disease.
“Our findings suggest that the Decipher Prostate test may provide an important new tool to help guide treatment decisions for the growing population of patients with metastatic prostate cancer,” said Professor Gerhardt Attard, director of UCL Cancer Institute and STAMPEDE trial co-investigator. “Treatment intensification with docetaxel, in addition to standard-of-care androgen deprivation therapy, is shown to improve survival for patients with metastatic prostate cancer. However, response rates vary and clinicians have had limited tools to identify who will likely benefit and who will not. Our results demonstrate the Decipher test’s ability to make this distinction.”
The study involved 1523 patients with high-risk or metastatic prostate cancer who were randomized to standard-of-care treatment with androgen deprivation therapy (ADT) or to chemotherapy plus ADT. Patients were then followed for a median of 14 years. Among the 832 patients with metastatic prostate cancer, those with higher Decipher Prostate scores had improved survival benefit (HR 0.64, 95% CI 0.48-0.86) from docetaxel, while those with lower Decipher scores did not (HR 0.96, 95% CI 0.71-1.30; biomarker-treatment interaction p=0.039).
The findings remained consistent, regardless of each patient’s metastatic disease volume. This is important because current clinical practice favors use of docetaxel in patients with high- but not low-volume disease.
“The Decipher Prostate test’s ability to help guide treatment for patients with localized prostate cancer has already been established in dozens of peer-reviewed publications and it is the only gene expression test to achieve ‘Level I’ evidence status in the most recent NCCN® Guidelines* for prostate cancer,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “This new publication provides important clinical evidence from a Phase 3 trial that supports expanded use of our test to patients with metastatic cancer—an area where there is a clear unmet need.”
Veracyte began making the Decipher test for metastatic prostate cancer broadly available to clinicians in the U.S. in June 2025. The expanded-use test was developed through an ongoing collaboration between Veracyte and University College London.
“The recent introduction of the Decipher test for metastatic prostate cancer reinforces the power of our Veracyte Diagnostics Platform. This platform helps harness our whole-transcriptome data-generation capabilities and our commitment to partnering with the research community to advance cancer understanding and innovation. Ultimately, our goal is to further help improve patient care,” said Phil Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer.
For the current study, Veracyte performed whole-transcriptome analysis of all prostate samples. In addition to the commercially available Decipher Prostate test, other research-use-only gene signatures were evaluated. One notable finding was that metastatic tumors with both a high Decipher Prostate test score and a PTEN-inactive gene signature had the greatest benefit from the addition of docetaxel, suggesting potential opportunities to enable further-personalized patient care in the future.
