On October 26, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported new data demonstrating the clinical utility of the company’s Decipher Prostate genomic classifier for guiding the timing and intensity of treatment in men experiencing prostate cancer progression following radical prostatectomy (Press release, Veracyte, OCT 26, 2021, View Source [SID1234591963]). The data, from a randomized, phase 3 trial conducted at 24 centers in Belgium, Germany, and Switzerland (SAKK 09/10), were presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2021 (abstract #94).

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Following radical prostatectomy, physicians typically monitor prostate cancer patients’ prostate-specific antigen (PSA) to identify biochemical recurrence. For those men who experience a subsequent rise in PSA, determining the optimal timing to initiate treatment and whether to add androgen deprivation therapy (ADT) to radiotherapy is challenging. Conventional clinical measures such as PSA and pathological findings following surgery are often insufficient to predict which patients will experience favorable oncologic outcomes with radiotherapy alone, and which will have disease that continues to progress.

To determine whether the Decipher Prostate genomic classifier could help identify those patients who would benefit from earlier intervention with radiotherapy or the addition of ADT to radiotherapy in this setting, researchers in the Swiss Group for Clinical Cancer Research (SAKK) and collaborating cancer centers assessed the outcomes and Decipher Prostate genomic risk for 226 prostate cancer patients from the SAKK 09/10 phase 3 randomized clinical trial. This study involved men experiencing a rise in PSA following radical prostatectomy, all of whom received radiotherapy without the addition of ADT. Patients in the Decipher Prostate analysis were followed for a median of 6.3 years.

"We’re pleased to have participated in this study, which explored a critical decision point in the management of men with prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s senior vice president of Scientific and Clinical Operations, Urologic Cancers. "The side effects of ADT when given concurrently with radiotherapy are often difficult for patients to manage. Being able to identify those patients who are likely to have favorable outcomes with radiotherapy alone, as well as the men who would benefit most from adding ADT to radiotherapy, could significantly improve the management of men with biochemically recurrent prostate cancer."

The data shared at ASTRO today show that men with disease classified as Decipher high-risk were more than twice as likely as those whose disease was classified as Decipher low/intermediate-risk to experience biochemical and clinical progression with radiotherapy alone. Additionally, Decipher high-risk patients with PSA levels above 0.5 ng/mL who received radiotherapy alone had a nearly 90% risk of cancer recurrence in the five years following treatment.

"The results of our study suggest that men with higher Decipher Prostate scores should be considered for earlier intervention when experiencing a rise in PSA, and depending on PSA level at time of treatment, these men may receive the most benefit from the addition of ADT to radiotherapy," said Alan Dal Pra, M.D., director of Clinical Research at Sylvester Comprehensive Cancer Center, associate professor of radiation oncology at the University of Miami Miller School of Medicine, and lead author on the ASTRO abstract. "This type of genomic, risk-based approach can support more informed, individualized treatment planning."