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

The retrospective findings add evidence for choosing who receives ADT; a separate prospective study has completed enrollment.

Rhea-AI Summary

Veracyte (VCYT) reported that a phase III trial analysis found its Decipher Prostate test predicts benefit from adding hormone therapy to radiation. The retrospective analysis examined short-term androgen deprivation therapy (ADT) in men with intermediate-risk prostate cancer. A treatment-by-Decipher interaction for distant metastasis was statistically significant (p<0.001).

Among patients with intermediate or high Decipher scores, adding ADT was associated with an 8% absolute reduction in distant metastasis at 10 years. For the 44% with low scores, the difference was 1 percentage point and was not statistically significant. Higher scores were also independently associated with greater risk of biochemical failure, distant metastasis and prostate-specific mortality. Researchers analyzed samples from 395 of the trial’s 1,492 participants, with a median follow-up of 10.2 years. A separate phase III study of Decipher-guided treatment changes completed enrollment earlier this year.

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Positive

• Moderate pointThe treatment-by-Decipher interaction for distant metastasis was statistically significant (p<0.001).
• Moderate pointIntermediate- or high-score patients had an 8% absolute reduction in 10-year distant metastasis with added ADT.
• Minor pointAmong the 44% with low scores, the 10-year difference was 1 percentage point and not statistically significant.
• Minor pointHigher scores were independently associated with greater risk of biochemical failure, distant metastasis and prostate-specific mortality.
• Minor pointThe separate phase III GUIDANCE study of Decipher-guided treatment changes completed enrollment earlier this year.

Negative

• Minor pointThe findings come from a retrospective ancillary analysis of samples from 395 trial participants.

Market Context

The Sep 25 disclosure of eight Decipher-focused ASTRO studies included research on ADT benefit; the ...

Analysis

The Sep 25 disclosure of eight Decipher-focused ASTRO studies included research on ADT benefit; the current announcement reports findings from that previously announced research program.

Key Figures

Treatment-by-Decipher interaction: p<0.001 Absolute reduction in distant metastasis: 8% Low-score group: 44% of patients +3 more

Treatment-by-Decipher interaction

p<0.001

Distant metastasis

Absolute reduction in distant metastasis

8%

At 10 years; intermediate/high Decipher scores with short-term ADT added to radiation

Low-score group

44% of patients

Patients with low Decipher scores

Absolute difference in distant metastasis

1 percentage point

At 10 years among patients with low Decipher scores; not statistically significant

Tumor samples analyzed

395 patients

NRG/RTOG 0815 ancillary analysis

Median follow-up

10.2 years

NRG/RTOG 0815 biomarker cohort

Key Terms

androgen deprivation therapy, distant metastasis, biochemical failure, prostate-specific mortality, +1 more

5 terms

androgen deprivation therapy medical

"short-term androgen deprivation therapy (ADT) in men with intermediate-risk prostate cancer"

Androgen deprivation therapy is a medical treatment that lowers or blocks male hormones (androgens) to slow the growth of hormone-sensitive cancers, most commonly prostate cancer. Think of it as cutting off the fuel a fire needs so the blaze slows; for investors, changes in ADT use, new ADT drugs, or clinical trial results can affect demand for medications, device procedures, safety profiles and long-term revenue for healthcare companies.

distant metastasis medical

"The treatment-by-Decipher interaction for distant metastasis was statistically significant"

Cancer cells that have left the original tumor and established new tumors in organs or tissues far from the primary site, typically by traveling through the bloodstream or lymphatic system. It matters to investors because distant metastasis strongly influences patient prognosis, the design and outcomes of clinical trials, regulatory decisions, and the potential market size and pricing for treatments — like a dandelion sending seeds that take root in new fields.

biochemical failure medical

"greater risk of biochemical failure, distant metastasis and prostate-specific mortality"

A biochemical failure is when a disease-related blood marker rises after treatment, suggesting the illness may be returning or progressing even if symptoms or scans look stable — think of it like a smoke alarm detecting smoke before you see flames. For investors, these early lab changes matter because they can signal a drug or medical device is less effective than hoped, affect clinical trial outcomes and regulatory decisions, and therefore influence a company’s future revenue and valuation.

prostate-specific mortality medical

"greater risk of biochemical failure, distant metastasis and prostate-specific mortality"

Prostate-specific mortality is the count or rate of deaths directly attributable to prostate cancer, as determined by death certificates, clinical adjudication, or registry coding rather than from other causes. Investors care about it because it is a hard clinical outcome used to judge how well treatments, screening programs, or diagnostics reduce deaths from prostate cancer—similar to tracking failures caused by a single defect rather than all failures when assessing a product’s true impact.

gleason grade medical

"clinical variables such as Gleason grade, PSA or clinical stage"

A Gleason grade is a pathologist’s assessment of how aggressive prostate cancer tissue looks under the microscope, expressed as a pair of pattern numbers (each 1–5) that are added into a Gleason score and often summarized into Grade Groups 1–5. It matters to investors because the grade influences prognosis, treatment choices and clinical-trial eligibility, which in turn affect the market value and regulatory prospects of drugs, devices and diagnostics tied to prostate cancer. Think of it like a tumor ‘report card’ that helps predict how the disease will behave.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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First predictive evidence in intermediate-risk prostate cancer supporting use of the Decipher test to guide short-term hormone therapy decisions to be presented at ASTRO 2026

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
   
   

Investors: 
Kelly Gura  
investors@veracyte.com

Media: 
Molly Cornbleet 
media@veracyte.com 
+1 650-351-8780

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Veracyte’s Decipher Prostate analysis show about adding hormone therapy to radiation?

Decipher scores distinguished groups with different outcomes after short-term ADT was added to radiation. The intermediate- or high-score group had an 8% absolute reduction in distant metastasis at 10 years; the low-score group had a 1-percentage-point difference that was not statistically significant.

How did the Decipher Prostate analysis select patients from the phase III trial?

Researchers analyzed tumor samples from 395 patients enrolled in NRG/RTOG 0815. The biomarker cohort was representative of the overall trial enrollment of 1,492 patients and was balanced between the treatment arms.