To treat or not to treat: Weighing the evidence

• Type of Material: Article
• Authors: Susan Halabi, Duke University; Bradley Carthon, Emory University; Wm Kevin Kelly, Thomas Jefferson University
• Language: English
• Date: 2023-10-23
• Publisher: American Medical Association
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2022, American Medical Association
• Final Published Version (URL): https://doi.org/10.1001%2Fjamaoncol.2022.1623
• Title of Journal or Parent Work: JAMA Oncology
• Volume: 8
• Issue: 8
• Start Page: 1137
• End Page: 1138
• Keywords: prostate cancer; enzalutamide; Active surveillance; ENACT
• Research Categories: Health Sciences, Oncology

Abstract

In this issue of JAMA Oncology, Shore et al. 1 present the results of the randomized phase II trial: the ENzalutamide Monotherapy Versus ACTive Surveillance in Patients With 2 Low- or Intermediate-Risk Localized Prostate Cancer (ENACT). Between June 2016 and August 2020227 men with prostate cancer were randomized with equal probability to either enzalutamide or active surveillance. The median age at randomization was 65 years and 53% of patients had low risk as determined by the National Comprehensive Cancer Network (NCCN) guidelines.2 Patients on the treatment arm were treated with 160 mg enzalutamide for 1 year with initial follow up for 1 year and a second year of follow up for remaining patients in the trial. The primary endpoint was time to pathological or therapeutic prostate cancer progression. Pathological progression in the study was defined as an increase in primary or secondary Gleason pattern by at least one or higher proportion of cancer-positive cores (≥15% increase). Therapeutic progression was considered upon primary therapy for prostate cancer whether this was prostatectomy, radiation, focal therapy, or any systemic therapy.