Evidence map›Paper›PMID 39948585›Full record

ArticleBMC cancer2025

A multicentre implementation trial of an Artificial Intelligence-driven biomarker to inform Shared decisions for androgen deprivation therapy in men undergoing prostate radiotherapy: the ASTuTE protocol.

Eric Wegener, Michael Ng, Mario Guerrieri, Timothy N Showalter, Jeremy de Leon, Sagar Ramani, Marcus Dreosti, Tee Lim, Bradley Wong, Michael Chao and 14 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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

24 authors.

Eric WegenerGenesisCare Lake Macquarie Private Hospital, 3 Sydney St Lake Macquarie, Gateshead, NSW, 2290, Australia. eric.wegener@genesiscare.com.
Michael NgGenesisCare St Vincent's Hospital, 41 Victoria Parade, Fitzroy, VIC, 3065, Australia.
Mario GuerrieriGenesisCare St Vincent's Hospital, 41 Victoria Parade, Fitzroy, VIC, 3065, Australia.
Timothy N ShowalterDepartment of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA.
Jeremy de LeonGenesisCare St Vincent's Hospital, Level A, 438 Victoria Street, Darlinghurst, NSW, 2010, Australia.
Sagar RamaniGenesisCare John Flynn Private Hospital, 42 Inland Drive, Tugun, QLD, 4224, Australia.
Marcus DreostiTennyson Centre, GenesisCare Kurralta Park, 520 South Road, Kurralta Park, SA, 5037, Australia.
Tee LimGenesisCare Fiona Stanley Hospital, 102-118 Murdoch Drive, Murdoch, WA, 6150, Australia.
Bradley WongGenesisCare Buderim, 10 King Street, Buderim, QLD, 4556, Australia.
Michael ChaoGenesisCare Ringwood Private Hospital, 36 Mount Dandenong Road, Ringwood East, VIC, 3135, Australia.
Kathryn HoganGenesisCare St Vincent's Hospital, Level A, 438 Victoria Street, Darlinghurst, NSW, 2010, Australia.
Avi RamanLingard Specialist Centre, Suite 3/2 Lingard St, Merewether, NSW, 2291, Australia.
Scott McClintockGold Coast Private Hospital, Level 3, 123 Nerang St, Southport, QLD, 4215, Australia.
Darren ForemanSouth Terrace Urology, 326 South Tce, Adelaide, SA, 5000, Australia.
Matthew BrownSt John of God Wexford Medical Centre, 3 Barry Marshall Parade, Murdoch, 6150, WA, Australia.
Stephen McCombieSt John of God Wexford Medical Centre, 3 Barry Marshall Parade, Murdoch, 6150, WA, Australia.
Kevin McMillanKnox Private Hospital, 262 Mountain Hwy, Wantirna, VIC, 3152, Australia.
Kieran BeattieSuite 6, Maitland Specialist Centre, 173 Chisholm Rd, East Maitland, NSW, 2323, Australia.
Mark FrydenbergAustralian Urology Associates, Ground Floor, 322 Glenferrie Rd, Malvern, VIC, 3144, Australia.
Lih-Ming WongMelbourne Urology Group, Suite 2, 141 Grey Street, East Melbourne, Australia.
Dickon HayneMedical School, The University of Western Australia, Perth, Australia.
John YaxleyWesley Urology Clinic, Suite 42, Level 4, Wesley Medical Centre, 40 Chasely Street, Auchenflower, QLD, 4066, Australia.
Phillip StrickerSt Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
Jarad MartinGenesisCare Lake Macquarie Private Hospital, 3 Sydney St Lake Macquarie, Gateshead, NSW, 2290, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAndrogen deprivation therapy (ADT) improves outcomes in men undergoing definitive radiotherapy for prostate cancer but carries significant toxicities. Clinical parameters alone are insufficient to accurately identify patients who will derive the most benefit, highlighting the need for improved patient selection tools to minimize unnecessary exposure to ADT's side effects while ensuring optimal oncological outcomes. The ArteraAI Prostate Test, incorporating a multimodal artificial intelligence (MMAI)-driven digital histopathology-based biomarker, offers prognostic and predictive information to aid in this selection. However, its clinical utility in real-world settings has yet to be measured prospectively.

methodsThis multicentre implementation trial aims to collect real-world data on the use of the previously validated Artera MMAI-driven prognostic and predictive biomarkers in men with intermediate-risk prostate cancer undergoing curative radiotherapy. The prognostic biomarker estimates the 10-year risk of metastasis, while the predictive biomarker determines the likely benefit from short-term ADT (ST-ADT). A total of 800 participants considering ST-ADT in conjunction with curative radiotherapy will be recruited from multiple Australian centers. Eligible patients with intermediate-risk prostate cancer, as defined by the National Comprehensive Cancer Network, will be asked to participate. The primary endpoint is the percentage of patients for whom testing led to a change in the shared ST-ADT recommendation, analyzed using descriptive statistics and McNemar's test comparing recommendations before and after biomarker testing. Secondary endpoints include the impact on quality of life and 5-year disease control, assessed through linkage with the Prostate Cancer Outcomes Registry. The sample size will be re-evaluated at an interim analysis after 200 patients. DISCUSSION: ASTuTE will determine the impact of a novel prognostic and predictive biomarker on shared decision-making in the short term, and both quality of life and disease control in the medium term. If the biomarker demonstrates a significant impact on treatment decisions, it could lead to more personalized treatment strategies for men with intermediate-risk prostate cancer, potentially reducing overtreatment and improving quality of life. A potential limitation is the variability in clinical practice across different centers inherent in real-world studies.

trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12623000713695p. Registered 5 July 2023.

Indexed as

Androgen AntagonistsArtificial IntelligenceBiomarkers, TumorProstatic NeoplasmsAustraliaClinical Trials as TopicHumansMaleMulticenter Studies as TopicPrognosisAndrogen AntagonistsBiomarkers, TumorAndrogen deprivation therapyArtificial IntelligenceBiomarkersDeep learningDigital pathology(MeSH): prostate cancerRadiotherapy

Identifiers

PMID39948585
PMCPMC11827432

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.