Veracyte, Inc. today announced the publication of data reinforcing the clinical utility of the Decipher Prostate genomic classifier for helping to guide the timing and intensity of therapy in men experiencing prostate cancer recurrence following radical prostatectomy (RP).
The findings, from an ancillary study of the prospective open-label, multicenter, randomized phase 3 SAKK 09/10 trial conducted at 28 centers in Belgium, Germany, and Switzerland, appear in Annals of Oncology.
It is estimated that more than 40 percent of men with intermediate- or high-risk prostate cancer may experience a biochemical disease recurrence after RP, which is characterized by rising levels of serum prostate-specific antigen (PSA). For men who experience a rising PSA, determining the optimal timing to initiate salvage radiotherapy (SRT) and whether to add androgen deprivation therapy (ADT) to SRT is challenging. This decision is important in part because the side effects of ADT when given concurrently with SRT are often difficult for patients to manage and are associated with long-term cardiovascular impact of hormone therapy.
“Each year in the United States, tens of thousands of men are diagnosed with biochemically recurrent prostate cancer, yet conventional clinical measures such as PSA and Gleason score are often insufficient to predict which of them will do well with SRT alone and who will need more intensive therapy to improve their oncologic outcomes,” said Elai Davicioni, Ph.D., Veracyte’s medical director for urology. “The data from this study suggest that the Decipher Prostate genomic classifier can help fill this gap by providing objective information to guide customized treatment planning in the postoperative setting.”
Researchers in the Swiss Group for Clinical Cancer Research (SAKK) and collaborating cancer centers assessed the clinical outcomes and Decipher Prostate genomic risk for 226 prostate cancer patients from the SAKK 09/10 trial, which randomized patients to standard vs. dose-escalated SRT. This study involved men experiencing a rise in PSA following RP, all of whom received SRT without the addition of ADT. Patients in the Decipher Prostate analysis were followed for a median of 6.3 years.
Findings suggest that Decipher Prostate can identify the patients who are at highest risk of cancer progression following RP and would benefit from earlier, more intensive treatment. Patients with a high Decipher score were more than twice as likely than those with a lower Decipher score to experience biochemical and clinical progression, and to receive long-term salvage hormone therapy. Additionally, patients with high Decipher scores had markedly improved outcomes when treated with SRT when the PSA burden was still low as compared to late SRT, when PSA levels have already risen.
“These findings add meaningfully to the existing literature supporting the use of the Decipher Prostate RP test in postoperative decision-making. Decipher Prostate RP is the only genomic test backed by evidence from randomized Phase 3 trials and we look forward to our continued collaboration with the SAKK team, with studies aimed at further elucidating the subset of men that benefit most from dose-escalation,” said Dr. Davicioni.
About Decipher Prostate
Decipher Prostate is a 22-gene, microarray-based genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis (Decipher Prostate Biopsy) and after surgical removal of the prostate (Decipher Prostate RP). 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. Decipher Prostate is available as part of Veracyte’s CLIA-validated laboratory-developed test (LDT) service. This test has not been cleared or approved by the FDA.