Decipher test validated in study of the practice-changing Phase 3 RTOG 96-01 clinical trial
SAN DIEGO, Feb. 11, 2021 /PRNewswire/ — Decipher Biosciences, a commercial-stage precision oncology company committed to improving patient care, with a focus in urologic oncology specific to prostate and bladder cancers, today announced publication of the results, in JAMA Oncology, from an analysis of the NRG Oncology Phase 3 randomized controlled trial RTOG 96-01. In this study, the Decipher Prostate RP, a radical prostatectomy post-surgery test, was clinically validated to predict overall survival and is believed to be the first known genomic test in localized prostate cancer to accomplish this milestone. The study, which followed patients for a median of 12 years, validated the Decipher RP test as an independent predictor of distant metastases, prostate cancer-specific mortality, and overall survival.
“This is very exciting, as the study validates Decipher Prostate as the first independent predictor of overall survival and shows how predicting metastatic risk with the Decipher test can be utilized to better guide treatment decisions in men with a prostate specific antigen (PSA) recurrence,” said Tina S. Nova, PhD, president and chief executive officer of Decipher Biosciences. “We consider this a significant milestone in the development of evidence for Decipher Prostate.”
Additionally, this study demonstrated that Decipher risk results were associated with hormone therapy benefit, with Decipher high-risk men having received greater absolute benefit from hormone therapy than Decipher low-risk men. In the subset of patients who received hormone therapy in addition to early salvage radiotherapy, Decipher high-risk men experienced improvements in distant metastasis, prostate cancer-specific mortality, and overall survival, while Decipher low-risk men had good oncologic outcomes without hormone therapy.
“Identifying which patients with recurrent disease are most likely to benefit from hormonal therapy will improve our ability to extend patient survival, while minimizing unnecessary toxicity for a large group of men with prostate cancer,” said Felix Feng, MD, vice chair of radiation oncology at University of California, San Francisco. “Decipher Prostate RP improves upon clinical and pathological risk stratification methods and informs the use of hormonal therapy, making it a reasonable and recommended component of the prostate cancer standard of care.”
About Decipher Prostate
Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, microarray-based genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.
About Decipher Biosciences
Decipher Biosciences is a commercial-stage precision oncology company committed to improving patient care, initially focused on urologic cancers. Our novel prostate cancer genomic test, Decipher Prostate, provides valuable information about the underlying biology of a patient’s tumor, assisting physicians in their selection of an optimal therapy. Our differentiated approach measures the biological activity of a patient’s entire tumor genome, known as whole transcriptome analysis, and applies proprietary machine learning algorithms to help physicians improve therapy selection and accelerate adoption of new therapies into the standard of care. Decipher Biosciences is headquartered in San Diego, California.