GenomeDx Biosciences, San Diego, recently announced publication of the first study to demonstrate the ability of the Decipher prostate cancer classifier biopsy test (Decipher Biopsy) to predict the development of metastasis after radiation and androgen deprivation therapy (ADT).
The study showed that Decipher Biopsy may accurately risk-stratify men for metastatic failure after first-line radiation and ADT.1
Radiation and ADT is a standard first-line therapy for patients diagnosed with intermediate- and high-risk prostate cancer. While many men can be cured with this treatment, there remains a proportion of men whose cancer will progress after therapy and develop into metastatic disease. For those men, intensification of therapy beyond standard radiation and ADT may be required to further reduce the risk of metastasis. However, it is important to correctly identify patients who would benefit from treatment intensification, due to an inherent risk of additional toxicity and side-effects associated with radiation and ADT treatment.
The study included a cohort of 100 men with intermediate- and high-risk prostate cancer who received definitive radiation plus a median of 6 months of ADT between 2001 and 2013, and had prostate biopsy samples available from the Dana-Farber/Brigham and Women’s Cancer Center. The samples were analyzed for genomic risk using Decipher Biopsy, as well as clinically using the standard risk models of the National Comprehensive Cancer Network (NCCN) and the University of California, San Francisco, cancer of the prostate risk assessment (CAPRA) categorizations—both of which are used to evaluate cancer recurrence.
After studying both genomic and clinical risk factors, the researchers found that Decipher Biopsy outperformed clinical variables and accurately predicted the 5-year and 10-year risk of distant metastasis, with concordance indices of 0.76 and 0.78, respectively. In addition, while the study included mostly men with intermediate-risk disease, in the 26% of men who were found to have a high Decipher-based genomic risk score (>0.60), 20% metastasized within 5 years of therapy despite their previous treatment. This finding suggests that such men may be candidates for treatment intensification or enrollment in clinical trials of a novel therapy.
“This study highlights the significant value that Decipher Biopsy may provide for patients who choose radiation as the primary management of their prostate cancer,” says the study’s lead author, Paul Nguyen, MD, radiation oncology leader in the genitourinary disease center at the Dana-Farber/Brigham and Women’s Cancer Center and Harvard Medical School. “The ability to detect which men harbor aggressive disease will allow clinicians to more accurately identify the optimal treatment to enhance disease control and ultimately improve outcomes in this patient population.”
Doug Dolginow, MD, GenomeDx.
“The findings from this study are meaningful and suggest that Decipher may help physicians make better-informed decisions about appropriate utilization of therapy at critical junctures in the care of prostate cancer patients,” says Doug Dolginow, MD, chief executive officer of GenomeDx. “Decipher Biopsy provides clinicians with the ability to improve risk assessment and tailor treatment approaches to further reduce a patient’s risk of metastasis.”
GenomeDx’s Decipher genomics resource information database (GRID) contains genomic profiles of thousands of tumors from patients with urological cancers. The company believes that GRID is the largest shared genomic expression database in urologic cancer as well as one of the world’s largest global RNA expression databases using cloud-based analytics. GRID is a platform for interactive research collaboration, and may enable more rapid discovery, development, commercialization, and adoption of new genomic solutions for key clinical questions in cancer treatment.
Derived from GRID, GenomeDx’s Decipher prostate cancer classifier tests are commercially available tests that provide a genomic assessment of tumor aggressiveness for individual patients. Decipher Biopsy is indicated for men with localized prostate cancer at diagnosis, and Decipher Post-Op is indicated for men after prostate removal surgery. The Decipher tests are used by physicians to stratify patients into more accurate risk groups than determined by traditional diagnostic tools, and to better determine which patients may be more likely to benefit from additional treatment. Each tumor analyzed with a Decipher test adds new data points to the GRID system, which is compiled into a Decipher GRID profile that may reveal additional biological characteristics of the tumor for ongoing research purposes.
For more information, visit GenomeDx.
REFERENCE
1. Nguyen PL, Martin NE, Choeurng V, et al. Utilization of biopsy-based genomic classifier to predict distant metastasis after definitive radiation and short-course ADT for intermediate and high-risk prostate cancer. Prostate Cancer Prostatic Dis. Advance online publication, January 24, 2017; doi: 10.1038/pcan.2016.58.
