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

Authors

null

Udit Singhal

University of Michigan (Ann Arbor, MI), Ann Arbor, MI

Udit Singhal , Stephanie Daignault-Newton , Rodney Dunn , Daniel Eidelberg Spratt , Linda Okoth , Felix Y Feng , Anna Johnson , Brian R Lane , Susan Linsell , Ghani Khurshid , Rohit Mehra , Elai Davicioni , Thomas Maatman , Frank Burks , Paul Rodriguez , Eduardo Kleer , Richard Sarle , David Christopher Miller , Michael L. Cher , Todd Matthew Morgan

Organizations

University of Michigan (Ann Arbor, MI), Ann Arbor, MI, University of Michigan, Ann Arbor, MI, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, University of California, San Francisco, San Francisco, CA, Spectrum Health, Grand Rapids, MI, Decipher Biosciences, San Diego, CA, Michigan Urological Clinic, Grand Rapids, MI, Comprehensive Urology, Royal Oak, MI, Urology Associates of Grand Rapids P.C, Grand Rapids, MI, IHA Urology, Ypsilanti, MI, Sparrow Regional Cancer Ctr. - Sparrow Medical Oncology, Lansing, MI, Wayne State University, Detroit, MI

Research Funding

U.S. National Institutes of Health
U.S. National Institutes of Health

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.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2023 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer - Advanced,Prostate Cancer - Localized

Sub Track

Symptoms, Toxicities, Patient-Reported Outcomes, and Whole-Person Care

Clinical Trial Registration Number

NCT02783950

Citation

J Clin Oncol 41, 2023 (suppl 6; abstr 345)

DOI

10.1200/JCO.2023.41.6_suppl.345

Abstract #

345

Poster Bd #

M3

Abstract Disclosures