Current randomized evidence supports consideration of adjuvant radiotherapy following prostatectomy in high-risk patients. However, only a limited number of men at high-risk of local recurrence after surgery receive adjuvant radiotherapy, and prior studies have shown there is marked variation in adjuvant radiotherapy utilization across urology practices. Decipher is a tissue-based genomic classifier (GC) developed and validated in the post-radical prostatectomy (RP) setting as a predictor of metastasis. We conducted the first prospective randomized trial assessing the impact of GC testing on adjuvant therapy use and report here patient characteristics and risk distribution of the cohort. We sought to determine the impact of GC testing on patient reported (PRO) quality of life outcomes in men at high-risk of post-prostatectomy recurrence.
The Genomics in Michigan ImpactiNg Observation or Radiation (G-MINOR) trial is a prospective, cluster-crossover, unblinded, randomized study of 356 patients from 12 centers in the Michigan Urological Surgery Improvement Collaborative (MUSIC). Patients were enrolled between January 2017 - August 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 based (UC) group using cluster-crossover block randomization assignments. Patients in both arms received a CAPRA-S derived recurrence risk score. PROs were obtained using the Expanded Prostate Cancer Index Composite (EPIC-26) survey at baseline, 3, 6, 12, and 24 months after surgery. A total of 240 patients completed pre-RP baseline surveys prior to enrollment and were eligible for the PRO portion of this study.
A total of 232/240 eligible patients (97%) had complete PRO data for this analysis. Median age was 65 years in both UC and GC groups, and baseline PSA was 6 ng/mL and 6.7 ng/mL in the UC and GC groups, respectively. 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 function (1.53, 95% CI [-1.48 – 4.55], p=0.32), urinary incontinence (1.08, 95% CI [-5.27 – 7.44], p=0.74), or sexual function (-2.26, 95% CI [-8.85 – 4.33], p=0.50). This remained true at 24 months for all three domains [urinary irritative function; (0.13, 95% CI [-3.06 – 3.33], p=0.93)], [urinary incontinence; (-1.26, 95% CI [-7.84 – 5.33], p=0.71)], [sexual function; (0.15, 95% CI [-6.77 – 7.07], p=0.97)](Figure 1-2).
In the first ever randomized trial testing the clinical utility of a genomic classifier in localized prostate cancer, longitudinal patient reported quality of life outcomes were not significantly different between study arms. While post-operative radiation use may be impacted by GC testing, no effect was observed on recovery of patient-reported urinary or sexual function.
Determining the impact of genomic classifier testing on patient-reported quality of life in men at high-risk of post-prostatectomy recurrence: results from G-MINOR randomized clinical trial
Category
Prostate Cancer > Potentially Localized
Description
Presented By: Udit Singhal
Authors: Udit Singhal
Jake R. Quarles
Daniel E. Spratt
Linda A. Okoth
Stephanie Daignault-Newton
Rodney Dunn
Felix Y. Feng
Anna Johnson
Brian R. Lane
Susan M. Linsell
Khurshid R. Ghani
James E. Montie
Brent K. Hollenbeck
Rohit Mehra
Elai Davicioni
Tamara R. Todorovic
Thomas J. Maatman
Kirk J. Wojno
Frank N. Burks
Paul Rodriguez
Eduardo Kleer
Richard Sarle
David C. Miller
Michael L. Cher
Todd M. Morgan