Evidence map›Paper›PMID 37035713›Full record

ArticleNIHR open research2022

Using the AR-V7 biomarker to determine treatment in metastatic castrate resistant prostate cancer, a feasibility randomised control trial, conclusions from the VARIANT trial.

Paul Gravestock, Emma Clark, Miranda Morton, Shirya Sharma, Holly Fisher, Jenn Walker, Ruth Wood, Helen Hancock, Nichola Waugh, Aislinn Cooper and 10 more

Abstract read
In one paragraph

Article in NIHR open research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Paul GravestockNewcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, Tyne and Wear, NE3 3HD, UK.ORCID https://orcid.org/0000-0003-2343-3418
Emma ClarkTranslational and Clinical Research Institute, NU Cancer, Newcastle upon Tyne, Tyne and Wear, NE1 7RU, UK.ORCID https://orcid.org/0000-0003-0065-1463
Miranda MortonNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, NE2 4AE, UK.
Shirya SharmaNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, NE2 4AE, UK.ORCID https://orcid.org/0000-0001-5237-757X
Holly FisherPopulation Health Sciences, Newcastle University, Newcastle upon Tyne, Tyne and Wear, NE1 7RU, UK.
Jenn WalkerNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, NE2 4AE, UK.
Ruth WoodNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, NE2 4AE, UK.ORCID https://orcid.org/0000-0002-8296-1774
Helen HancockNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, NE2 4AE, UK.
Nichola WaughNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, NE2 4AE, UK.
Aislinn CooperVelindre University NHS Trust, Cardiff, CF15 7QZ, UK.
Rebecca MaierNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, NE2 4AE, UK.ORCID https://orcid.org/0000-0002-7350-3288
John MarshallTrial Management Group, VARIANT Trial, Newcastle upon Tyne, Tyne and Wear, NE1 7RU, UK.ORCID https://orcid.org/0000-0001-9272-9410
Robert ChandlerNewcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, Tyne and Wear, NE3 3HD, UK.
Amit BahlUniversity Hospitals Bristol NHS Foundation Trust, Bristol, BS1 3NU, UK.
Simon CrabbUniversity of Southampton, Southampton, Hampshire, SO17 1BJ, UK.
Suneil JainQueens University Belfast, Belfast, BT7 1NN, UK.
Ian PedleyNewcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, Tyne and Wear, NE3 3HD, UK.
Rob JonesInstitute of Cancer Services, University of Glasgow, Glasgow, G12 0YN, UK.
John Staffurth *Velindre University NHS Trust, Cardiff, CF15 7QZ, UK.ORCID https://orcid.org/0000-0002-7834-3172
Rakesh Heer *Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, Tyne and Wear, NE3 3HD, UK.

Funding

Department of Health PB-PG-0816-20043
6 · The paper itself

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.

Indexed as

biomarkerscastration-resistantfeasibility studiesmaleprostatic neoplasms

Identifiers

PMID37035713
PMCPMC7614403

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.