Phase III Trial Demonstrates Veracyte’s Decipher Prostate Test Predicts Benefit from Adding Hormone Therapy to Radiation

SOUTH SAN FRANCISCO, Calif., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, announced that new findings from a retrospective ancillary analysis of the randomized phase III NRG/RTOG 0815 trial will be presented at the 2026 American Society for Radiation Oncology (ASTRO) Annual Meeting. The trial evaluated dose-escalated radiation with or without short-term androgen deprivation therapy (ADT) in men with intermediate-risk prostate cancer. The analysis showed that the Decipher Prostate Genomic Classifier can predict which patients are more likely to benefit from adding short-term ADT to dose-escalated radiation, providing both Level 1B¹ prognostic and predictive evidence.

In the study, patients with higher Decipher scores had substantially improved outcomes with the addition of short-term ADT to radiation, while patients with low Decipher scores derived minimal treatment benefit. These findings extend Decipher’s long-established role in assessing the risk of prostate cancer progression to informing treatment selection for patients with intermediate-risk disease. The results will be presented today at 3:55 p.m. ET in an oral session at the 2026 ASTRO Annual Meeting by Angela Jia, M.D., Ph.D., University Hospitals Seidman Cancer Center, Case Western Reserve University.

“For men with intermediate-risk prostate cancer, the question is not simply whether hormone therapy works — it is who truly needs it,” said Angela Jia, M.D., Ph.D. “This analysis suggests tumor biology can distinguish patients who may achieve a substantial reduction in the risk of distant metastasis from those who may see little added benefit. That could help clinicians and patients make a more individualized decision about intensifying treatment.”

While ADT can reduce the risk of recurrence and distant spread, it can also have metabolic and quality-of-life effects. Because intermediate-risk disease is biologically diverse, clinical variables such as Gleason grade, PSA or clinical stage may not reveal which patients are most likely to benefit from adding the therapy.

Key study findings:

• Decipher predicted differential benefit from hormone therapy: The treatment-by-Decipher interaction for distant metastasis was statistically significant (p<0.001).
• Patients with higher scores experienced substantially greater benefit: Among patients with intermediate/high Decipher scores, adding short-term ADT was associated with an 8% absolute reduction in distant metastasis at 10 years.
• Patients with low scores did not have substantial benefit from short-term ADT: Among the 44% of patients with low Decipher scores, the absolute difference in 10-year distant metastasis was 1 percentage point and was not statistically significant.
  

Decipher also refined prognosis: Higher scores were independently associated with greater risk of biochemical failure, distant metastasis and prostate-specific mortality. Researchers analyzed tumor samples from 395 patients enrolled in NRG/RTOG 0815, with a median follow up of 10.2 years. The biomarker cohort was representative of the overall trial enrollment of 1,492 patients and was balanced between treatment arms. The Decipher score was both prognostic for disease outcomes and predictive of ADT benefit for both distant metastasis as well as prostate cancer specific mortality endpoints.

“For men with intermediate-risk prostate cancer, these findings provide predictive evidence that treatment decisions can be guided by the biology of each patient's tumor, not simply a broad clinical risk category,” said Daniel E. Spratt, M.D., chair of the Department of Radiation Oncology at University Hospitals Cleveland Medical Center, professor at Case Western Reserve University School of Medicine, and a study author. “Decipher may help identify who is likely to gain meaningful protection from metastasis by adding hormone therapy and who may face its health and quality-of-life effects with little added benefit. That is the kind of precision that patients and physicians need when deciding how aggressively to treat the cancer.”

“These findings provide the first evidence that Decipher can predict which men with intermediate-risk prostate cancer are most likely to benefit from adding hormone therapy to radiation,” said Elai Davicioni, Ph.D., Veracyte’s medical director, Urology. “This extends the Decipher test’s prognostic use toward answering a more consequential question: Will this treatment make a meaningful difference for this patient? By revealing the biology beneath a broad clinical risk category, Decipher may help physicians intensify treatment for patients most likely to benefit while potentially sparing others from side effects with little added benefit. With the addition of these findings, we believe that all men diagnosed with intermediate-risk prostate cancer may benefit from the use of Decipher in their care pathway.”

ASTRO 2026 presentation details

Abstract #312: Genomic Stratification of Benefit from Short-Term Androgen Deprivation with Dose-Escalated Radiotherapy in Intermediate-Risk Prostate Cancer: An Ancillary Study of NRG/RTOG 0815

• Session: SS 36 - Predicting Benefit and Toxicity: Biomarkers in Prostate Radiotherapy
• Presenter: Angela Jia, M.D., Ph.D.
• Date and time: Tuesday, September 29, 2026, 3:55–4:05 p.m. ET
• Location: Room 210, Thomas M. Menino Convention & Exhibition Center, Boston
  

Another trial prospectively evaluating the use of the Decipher prostate test to guide treatment intensification or de-intensification is the phase III biomarker-driven NRG-GU010 (GUIDANCE) study, which completed enrollment earlier this year. This trial will build on the findings from the NRG/RTOG 0815 trial, further expanding the predictive evidence around the Decipher test in intermediate-risk disease.

About the NRG/RTOG 0815 analysis

NRG/RTOG 0815 was a randomized phase III trial evaluating the addition of short-term ADT to dose-escalated radiation in patients with intermediate-risk prostate cancer. In this NCI-approved ancillary analysis, archived diagnostic biopsy specimens were evaluated using the locked, clinical-grade 22-gene Decipher Genomic Classifier. The analysis included 395 patients with a median follow-up of 10.2 years. The primary endpoint was distant metastasis; secondary endpoints included biochemical failure, metastasis-free survival, prostate cancer-specific mortality and overall survival.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company with a vision to transform cancer care for patients around the world. The company’s molecular tests assess the unique biology of each patient’s tumor to help clinicians answer essential questions about cancer care. Veracyte’s Diagnostics Platform combines broad genomic and clinical data, advanced bioinformatics and AI, and a powerful evidence-generation engine to support continued innovation and pipeline development. The company’s portfolio includes the Afirma® Genomic Sequencing Classifier test, Decipher® Bladder Genomic Classifier test, Decipher® Prostate Genomic Classifier test, Prosigna® Breast Risk of Recurrence test, and the TrueMRD™ Monitoring Test for MIBC. For more information, visit Veracyte’s website or follow the company on LinkedIn or X (Twitter).  

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to statements regarding the potential clinical utility, impact and benefits of the Decipher Prostate Genomic Classifier; the ability of the Decipher Prostate test to predict which patients with intermediate-risk prostate cancer may benefit from the addition of short-term ADT; the potential use of Decipher to inform treatment selection and personalize treatment decisions; the potential for Decipher to expand beyond risk assessment to guide treatment decisions in intermediate-risk prostate cancer; and the significance and clinical implications of the study findings, and the potential outcomes, validation and impact of the ongoing NRG-GU010 GUIDANCE clinical trial. Forward-looking statements can be identified by words such as “appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will,” “enable,” “positioned,” “offers,” “designed,” “ultimately,” and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions. Additional factors that may impact these forward-looking statements can be found under the caption 'Risk Factors' in our Annual Report on Form 10-K filed on February 26, 2026, as well as in other documents that we may file from time to time with the Securities and Exchange Commission. Copies of these documents, when available, may be found in the Investors section of our website at investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.

References:

1. Simon, R. M., Paik, S. & Hayes, D. F. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst 101, 1446–1452 (2009). https://doi.org/10.1093/jnci/djp335
   

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