Determining the impact of genomic classifier testing on patient-reported quality of life after prostatectomy: Results from the G-MINOR randomized trial.

Abstract

345 Background: Decipher is a tissue-based genomic classifier (GC) developed and validated in the post-radical prostatectomy (RP) setting to help guide adjuvant treatment decisions for prostate cancer (PCa). We conducted the first prospective, randomized trial assessing the impact of GC testing on adjuvant therapy use. Here, we determine the impact of GC testing on patient reported (PRO) quality of life outcomes (QoL) in men at high-risk of post-RP recurrence. Methods: The G-MINOR trial is a prospective, unblinded, randomized trial which enrolled 356 patients from 12 centers in the Michigan Urological Surgery Improvement Collaborative (MUSIC). Patients were enrolled between Aug 2016-July 2018. Eligible patients had undergone RP within 9 months of enrollment, had pT3-4 disease and/or positive surgical margins, and a post-RP PSA <0.1ng/mL. Patients were assigned to either the GC or usual-care (UC) group using cluster-crossover block randomization assignments. Evaluable patients (338) were followed for at least 18 months. PROs were obtained using the Expanded Prostate Cancer Index Composite (EPIC-26) survey at baseline (before RP), 3, 6, 12, and 24 months after RP. Results: A total of 226/338 evaluable men (67%) had PRO data for this analysis (116 UC arm/110 GC arm). Median age was 65 years. Of the 226 men included in the PRO analysis, a total of 23 (9 UC arm/14 GC arm) had adjuvant treatment (p = 0.22). At 12 months follow-up, those in the GC arm had no significant change in adjusted mean difference in domain score from baseline compared to those in the UC arm for urinary irritative (UIR) function (1.0, 95% CI [-2.9– 4.9], p=0.6), urinary incontinence (UI) (0.8, 95% CI [-5.1– 6.7], p=0.8), or sexual function (SF) (0.5, 95% CI [-6.9– 7.9], p=0.9). This remained true at 24 months for all three domains [UIR; (2.3, 95% CI [-2.1– 6.6], p=0.3)], [UI; (-0.3, 95% CI [-7.3– 6.7], p=0.9)], [SF; (1.5, 95% CI [-6.8– 9.7], p=0.7)]. Conclusions: In the first ever randomized trial testing the clinical utility of a GC test in localized PCa, longitudinal patient reported QOL outcomes were not significantly different between men who underwent risk stratification with or without Decipher. Clinical trial information: NCT02783950 .