To report patient-reported outcomes (PROs) of a phase III trial evaluating total androgen suppression (TAS) combined with dose-escalated radiation therapy (RT) for patients with intermediate-risk prostate cancer.
Patients with intermediate-risk prostate cancer were randomly assigned to dose-escalated RT alone (arm 1) or RT plus TAS (arm 2) consisting of luteinizing hormone-releasing hormone agonist/antagonist with oral antiandrogen for 6 months. The primary PRO was the validated Expanded Prostate Cancer Index Composite (EPIC-50). Secondary PROs included Patient-Reported Outcome Measurement Information System (PROMIS)-fatigue and EuroQOL five-dimensions scale questionnaire (EQ-5D). PRO change scores, calculated for each patient as the follow-up score minus baseline score (at the end of RT and at 6, 12, and 60 months), were compared between treatment arms using a two-sample t test. An effect size of 0.50 standard deviation was considered clinically meaningful.
For the primary PRO instrument (EPIC), the completion rates were ≥86% through the first year of follow-up and 70%-75% at 5 years. For the EPIC hormonal and sexual domains, there were clinically meaningful (P < .0001) deficits in the RT + TAS arm. However, there were no clinically meaningful differences by 1 year between arms. There were also no clinically meaningful differences at any time points between arms for PROMIS-fatigue, EQ-5D, and EPIC bowel/urinary scores.
Compared with dose-escalated RT alone, adding TAS demonstrated clinically meaningful declines only in EPIC hormonal and sexual domains. However, even these PRO differences were transient, and there were no clinically meaningful differences between arms by 1 year.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2023 Apr 27 [Epub ahead of print]
Benjamin Movsas, Joseph P Rodgers, Mohamed A Elshaikh, Alvaro A Martinez, Gerard C Morton, Daniel J Krauss, Di Yan, Deborah E Citrin, Bruce W Hershatter, Jeff M Michalski, Rodney J Ellis, Vivek S Kavadi, Elizabeth M Gore, Gary S Gustafson, Craig A Schulz, Vikram M Velker, Adam C Olson, Fabio L Cury, Michael A Papagikos, Theodore G Karrison, Howard M Sandler, Deborah W Bruner
Henry Ford Cancer Institute, Detroit, MI., NRG Oncology Statistics and Data Management Center, Philadelphia, PA., 21st Century Oncology MHP, Farmington Hills, MI., Odette Cancer Centre-Sunnybrook Health Sciences Centre, Toronto, ON, Canada., William Beaumont Hospital, Royal Oak, MI., Center for Cancer Research, National Cancer Institute, Bethesda, MD., Emory University Hospital/Winship Cancer Institute, Atlanta, GA., Washington University School of Medicine, Saint Louis, MO., Penn State Milton Hershey Medical Center, Hershey, PA., The US Oncology Network, Sugar Land, TX., Froedtert and the Medical College of Wisconsin and Zablocki VAMC, Milwaukee, WI., Beaumont NCI Community Oncology Research Program, Troy, MI., Columbia Saint Mary's Water Tower Medical Commons, Milwaukee, WI., London Regional Cancer Program, London, ON, Canada., University of Pittsburgh Cancer Institute, Pittsburgh, PA., The Research Institute of the McGill University Health Centre (MUHC), Montreal, QC, Canada., Novant Health New Hanover Regional Medical Center-Zimmer Cancer Institute, Wilmington, NC., NRG Oncology Statistics and Data Management Center, Chicago, IL., Cedars-Sinai Medical Center, Los Angeles, CA.