Prospective randomized trial of genomic classifier impact on treatment decisions in patients at high risk of recurrence following radical prostatectomy (G-MINOR).

2018 
TPS154Background: Approximately 30% of patients will have ≥pT3 disease and/or positive surgical margins at radical prostatectomy (RP), indicating a high risk of local recurrence. While current guidelines recommend consideration of adjuvant radiotherapy (aRT) in this setting, < 10% undergo aRT. The Decipher assay is a novel, tissue-based genomic classifier (GC) developed and validated in the post-RP setting as a predictor of metastasis. Current retrospective evidence suggests that patients with a high GC score may benefit from aRT, while observation may be safe for those with a lower GC score. However, there are no randomized prospective data evaluating the clinical utility of biomarkers in men with adverse features after RP. Here we see to determine the impact of GC test results on adjuvant treatment decisions for high-risk post-RP patients vs. clinical factors alone. Methods: Genomics in Michigan ImpactiNg Observation or Radiation (G-MINOR) is a 4-year (12-month enrollment, 3-year follow-up) prospective,...
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