Five-year follow-up study of a population-based prospective cohort of men with low-risk prostate cancer: the treatment options in prostate cancer study (TOPCS): study protocol

• Type of Material: Article
• Authors: Jinping Xu, Wayne State University; Michael Goodman, Emory University; James Janisse, Wayne State University; Michael L Cher, Wayne State University; Cathryn Hufford Bock, Wayne State University
• Language: English
• Date: 2022-02-01
• Publisher: BMJ PUBLISHING GROUP
• Publication Version: Final Published Version
• Copyright Statement: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1136/bmjopen-2021-056675
• Title of Journal or Parent Work: BMJ OPEN
• Volume: 12
• Issue: 2
• Start Page: e056675
• End Page: e056675
• Grant/Funding Information: This work is supported by the Department of Defense of the USA, grant number: DoD#W81XWH910794; and the American Cancer Society, grant number: RSG1316401CPPB.
• Keywords: VALIDATION; adult urology; ACTIVE-SURVEILLANCE PROGRAM; quality in health care; mental health; Life Sciences & Biomedicine; Science & Technology; urological tumours; OUTCOMES; Medicine, General & Internal; REGRET; CARE; GUIDELINES; adult surgery; RADICAL PROSTATECTOMY; QUALITY-OF-LIFE; DECISION-MAKING; adult radiotherapy; General & Internal Medicine; SURVIVAL
• Research Categories: Health Sciences, Oncology; Health Sciences, Epidemiology; Health Sciences, Public Health

Abstract

Introduction Active surveillance (AS) is recommended for men with low-risk prostate cancer (LRPC) to reduce overtreatment and to maintain patients' quality of life (QOL). However, whether African American (AA) men can safely undergo AS is controversial due to concerns of more aggressive disease and lack of empirical data on the safety and effectiveness of AS in this population. Withholding of AS may lead to a lost opportunity for improving survivorship in AA men. In this study, peer-reviewed and funded by the US Department of Defense, we will assess whether AS is an equally effective and safe management option for AA as it is for White men with LRPC. Methods and analysis The project extends follow-up of a large contemporary population-based cohort of LRPC patients (n=1688) with a high proportion of AA men (∼20%) and well-characterised baseline and 2-year follow-up data. The objectives are to (1) determine any racial differences in AS adherence, switch rate from AS to curative treatment and time to treatment over 5 years after diagnosis, (2) compare QOL among AS group and curative treatment group over time, overall and by race and (3) evaluate whether reasons for switching from AS to curative treatment differ by race. Validation of survey responses related to AS follow-up procedures is being conducted through medical record review. We expect to obtain 5-year survey from ∼900 (∼20% AA) men by the end of this study to have sufficient power. Descriptive and inferential statistical techniques will be used to examine racial differences in AS adherence, effectiveness and QOL. Ethics and dissemination The parent and current studies were approved by the Institutional Review Boards at Wayne State University and Emory University. Since it is an observational study, ethical or safety risks are low. We will disseminate our findings to relevant conferences and peer-reviewed journals.