Gravestock, Paul, Clark, Emma, Morton, Miranda, Sharma, Shirya, Fisher, Holly, Walker, Jenn, Wood, Ruth, Hancock, Helen, Waugh, Nichola, Cooper, Aislinn, Maier, Rebecca, Marshall, John, Chandler, Robert, Bahl, Amit, Crabb, Simon, Jain, Suneil, Pedley, Ian, Jones, Rob, Staffurth, John and Heer, Rakesh (2023) Using the AR-V7 biomarker to determine treatment in metastatic castrate resistant prostate cancer, a feasibility randomised control trial, conclusions from the VARIANT trial: [version 2; peer review: 2 approved]. NIHR open research, 2, [49]. (doi:10.3310/nihropenres.13284.2).
Abstract
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.
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