Browse by author
Lookup NU author(s): Dr Emma ClarkORCiD, Dr Holly FisherORCiD, Jenn Walker, Ruth Wood, Professor Helen HancockORCiD, Nichola Waugh, Rebecca Maier, Professor Rakesh Heer
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Copyright: © 2023 Gravestock P et al. Background: Prostate cancer is the most commonly diagnosed malignancy in the UK. Castrate resistant prostate cancer (CRPC) can be difficult to manage with response to next generation hormonal treatment variable. AR-V7 is a protein biomarker that can be used to predict response to treatment and potentially better inform management in these patients. Our aim was to establish the feasibility of conducting a definitive randomised controlled trial comparing the clinical utility of AR-V7 biomarker assay in personalising treatments for patients with metastatic CRPC within the United Kingdom (UK) National Health Service (NHS). Due to a number of issues the trial was not completed successfully, we aim to discuss and share lessons learned herein. Methods: We conducted a randomised, open, feasibility trial, which aimed to recruit 70 adult men with metastatic CRPC within three secondary care NHS trusts in the UK to be run over an 18-month period. Participants were randomised to personalised treatment based on AR-V7 status (intervention) or standard care (control). The primary outcome was feasibility, which included: recruitment rate, retention and compliance. Additionally, a baseline prevalence of AR-V7 expression was to be estimated. Results: Fourteen participants were screened and 12 randomised with six into each arm over a nine-month period. Reliability issues with the AR-V7 assay meant prevalence was not estimated. Due to limited recruitment the study did not complete to target. Conclusions: Whilst the trial did not complete to target, we have ascertained that men with advanced cancer are willing to take part in trials utilising biomarker guided treatment. A number of issues were identified that serve as important learning points in future clinical trials.
Author(s): Gravestock P, Clark E, Morton M, Sharma S, Fisher H, Walker J, Wood R, Hancock H, Waugh N, Cooper A, Maier R, Marshall J, Chandler R, Bahl A, Crabb S, Jain S, Pedley I, Jones R, Staffurth J, Heer R
Publication type: Article
Publication status: Published
Journal: NIHR Open Research
Year: 2023
Volume: 2
Online publication date: 10/01/2023
Acceptance date: 10/01/2023
Date deposited: 21/08/2024
ISSN (electronic): 2633-4402
Publisher: F1000 Research Ltd
URL: https://doi.org/10.3310/nihropenres.13284.2
DOI: 10.3310/nihropenres.13284.2
Data Access Statement: Underlying data from this study are available on request from the corresponding author, Rakesh Heer (rakesh.heer@ newcastle.ac.uk). The data is not available publicly due to confidentiality restrictions. Access to de-identified data collected during the trial, may be granted to researchers who submit a methodologically sound proposal. To gain access, data requestors will need to complete forms required as part of the application process. Zenodo: Extended data for ‘Using the AR-V7 biomarker to determine treatment in metastatic castrate resistant prostate cancer, a feasibility randomised control trial, conclusions from the VARIANT trial’. https://doi.org/10.5281/zenodo.6874339 Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0)
Altmetrics provided by Altmetric
