An update to the NCCN Clinical Practice Guidelines for Oncology recommends using the Decipher Prostate genomic classifier to help guide treatment in men with high-risk prostate cancer following radical prostatectomy (RP), according to Veracyte, the developer of the test.1
Specifically, the guidelines stipulate that for men with a high-risk Decipher score (>0.6 on a scale of 0-1), clinicians should strongly consider salvage radiotherapy with concurrent hormone therapy in instances when early radiation therapy is missed.
“We are thrilled that Decipher Prostate RP is now recommended by the NCCN to guide specific treatment decisions,” Elai Davicioni, PhD, senior vice president, scientific and clinical operations, urologic cancers, at Veracyte stated in a press release. “The NCCN’s designation is unique to Decipher Prostate RP and underscores the extensive clinical validation and clinical utility data behind the test. We believe this recommendation will ultimately enable more men to receive the treatment they need, while reducing unnecessary therapy.”
The NCCN made this update to its guidelines based on data from the randomized controlled phase 3 RTOG 96-01 trial. An ancillary analysis of the pivotal trial clinically validated Decipher Prostate as a predictor of overall survival (OS) in men with biochemically recurrent prostate cancer after RP.2 In the analysis, Decipher scores were independently associated with OS, prostate cancer–specific mortality, and risk of metastasis.
The ancillary study used RP specimens obtained in the practice-changing RTOG 96-01 (NCT00002874) randomized clinical trial. These specimens from that phase 3 placebo-controlled study were collected between March 1998 and March 2003. The double-blind NRG/RTOG 9601 study included 760 patients with recurrent pT3N0 prostate cancer after RP and pelvic lymphadenectomy.3 Patients were randomized to receive radiation therapy with either antiandrogen therapy (24 months of daily bicalutamide) or placebo tablets daily during and after radiation therapy. OS was the primary end point.
In the primary analysis of RTOG 96-01, the OS rate at 12 years was 76.3% in the bicalutamide arm versus 71.3% in the placebo arm, translating to a 33% reduction in the risk of death (HR, 0.77; P = .04). Prostate cancer–related death at 12 years occurred in 5.8% versus 13.4% of the 2 arms, respectively (P <.001).
For the ancillary study, the researchers used specimens from 352 men randomized to either placebo or hormone therapy in NRG/RTOG 9601. The median age of these men was 64.5 years (range, 60-70) and 89.2% were White. Statistical modeling showed that Decipher was independently associated with distant metastasis (HR, 1.17; P = .006), prostate cancer–specific mortality (HR, 1.39; P <.001), and OS (HR, 1.17; P = .002).
The authors of the ancillary study also noted in their abstract that, “the estimated absolute effect of bicalutamide on 12-year OS was less when comparing patients with lower vs higher [Decipher] scores (2.4% vs 8.9%), which was further demonstrated in men receiving early salvage radiation therapy at a prostate-specific antigen level lower than 0.7 ng/mL (−7.8% vs 4.6%).”2
1. Veracyte Announces that New NCCN Guidelines Uniquely Recommend Use of Decipher Prostate Genomic Test Score to Guide Specific Treatment for Men Following Radical Prostatectomy. Published online September 14, 2021. Accessed September 15, 2021. https://bwnews.pr/2Xnm4fu.
2. Feng FY; Huang H-C, Spratt DE, et al. Validation of a 22-gene genomic classifier in patients with recurrent prostate cancer: an ancillary study of the NRG/RTOG 9601 randomized clinical trial [published online ahead of print February 11, 2021]. JAMA Oncol. doi: 10.1001/jamaoncol.2020.7671
3. Shipley WU, Seiferheld W, Lukka HR, et al. Radiation with or without antiandrogen therapy in recurrent prostate cancer. N Engl J Med. 2017 Feb 2;376(5):417-428. doi: 10.1056/NEJMoa1607529