Evidence map›Paper›PMID 30527787›Full record

Trial reportEuropean urology2019

The SmartTarget Biopsy Trial: A Prospective, Within-person Randomised, Blinded Trial Comparing the Accuracy of Visual-registration and Magnetic Resonance Imaging/Ultrasound Image-fusion Targeted Biopsies for Prostate Cancer Risk Stratification.

Sami Hamid, Ian A Donaldson, Yipeng Hu, Rachael Rodell, Barbara Villarini, Ester Bonmati, Pamela Tranter, Shonit Punwani, Harbir S Sidhu, Sarah Willis and 11 more

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European urology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05241236 (Office Based MRI/Ultrasound Guided Prostate Cancer Ablation), which is not on this map. Cited by 46 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 2 pooled it
–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.

NCT05241236 recruitingnot on this mapstarted 2020, after this paper: background citation

Office Based MRI/Ultrasound Guided Prostate Cancer Ablation: Outcomes Registry

Typeobservational_patient_registrySponsorUrological Research Network, LLCRan2020 to 2038Enrolled5,000ConditionsNeoplasms Prostate, Cancer of the ProstateArmsImage Fusion (MR/US) Software Registration Guided Laser Ablation of Prostate Cancer
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Results of fusion prostate biopsy comparing with cognitive and systematic biopsy.Journal of cancer research and clinical oncology · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Sami HamidResearch Department of Urology, Division of Surgery and Interventional Science, Faculty of Medicine, University College London, London, UK; Department of Urology, UCLH NHS Foundation Trust, London, UK.
Ian A DonaldsonResearch Department of Urology, Division of Surgery and Interventional Science, Faculty of Medicine, University College London, London, UK; Department of Urology, UCLH NHS Foundation Trust, London, UK.
Yipeng HuUCL Centre for Medical Image Computing, Department of Medical Physics & Biomedical Engineering, University College London, London, UK.
Rachael RodellUCL Centre for Medical Image Computing, Department of Medical Physics & Biomedical Engineering, University College London, London, UK.
Barbara VillariniUCL Centre for Medical Image Computing, Department of Medical Physics & Biomedical Engineering, University College London, London, UK.
Ester BonmatiUCL Centre for Medical Image Computing, Department of Medical Physics & Biomedical Engineering, University College London, London, UK.
Pamela TranterTranslational Research Office, School of Life and Medical Sciences, University College London, London, UK.
Shonit PunwaniDepartment of Radiology, UCLH NHS Foundation Trust, London, UK; Centre for Medical Imaging, Division of Medicine, Faculty of Medicine, University College London, London, UK.
Harbir S SidhuDepartment of Radiology, UCLH NHS Foundation Trust, London, UK; Centre for Medical Imaging, Division of Medicine, Faculty of Medicine, University College London, London, UK.
Sarah WillisDepartment of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.
Jan van der MeulenDepartment of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.
David HawkesUCL Centre for Medical Image Computing, Department of Medical Physics & Biomedical Engineering, University College London, London, UK.
Neil McCartanResearch Department of Urology, Division of Surgery and Interventional Science, Faculty of Medicine, University College London, London, UK; Surgical and Interventional Trials Unit, Division of Surgery and Interventional Science, Faculty of Medical Sciences, University College London, London, UK.
Ingrid PotykaSurgical and Interventional Trials Unit, Division of Surgery and Interventional Science, Faculty of Medical Sciences, University College London, London, UK.
Norman R WilliamsSurgical and Interventional Trials Unit, Division of Surgery and Interventional Science, Faculty of Medical Sciences, University College London, London, UK.
Chris Brew-GravesSurgical and Interventional Trials Unit, Division of Surgery and Interventional Science, Faculty of Medical Sciences, University College London, London, UK.
Alex FreemanDepartment of Pathology, UCLH NHS Foundation Trust, London, UK.
Caroline M MooreResearch Department of Urology, Division of Surgery and Interventional Science, Faculty of Medicine, University College London, London, UK; Department of Urology, UCLH NHS Foundation Trust, London, UK.
Dean BarrattUCL Centre for Medical Image Computing, Department of Medical Physics & Biomedical Engineering, University College London, London, UK.
Mark EmbertonResearch Department of Urology, Division of Surgery and Interventional Science, Faculty of Medicine, University College London, London, UK; Department of Urology, UCLH NHS Foundation Trust, London, UK.
Hashim U AhmedResearch Department of Urology, Division of Surgery and Interventional Science, Faculty of Medicine, University College London, London, UK; Department of Urology, UCLH NHS Foundation Trust, London, UK; Centre for Medical Imaging, Division of Medicine, Faculty of Medicine, University College London, London, UK; Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Imperial Urology, Imperial College Healthcare NHS Trust, London, UK. Electronic address: hashim.ahmed@imperial.ac.uk.

Funding

Cancer Research UK 16463Department of HealthWellcome Trust
6 · The paper itself

Abstract

backgroundMultiparametric magnetic resonance imaging (mpMRI)-targeted prostate biopsies can improve detection of clinically significant prostate cancer and decrease the overdetection of insignificant cancers. It is unknown whether visual-registration targeting is sufficient or augmentation with image-fusion software is needed.

objectiveTo assess concordance between the two methods. DESIGN, SETTING, AND

participantsWe conducted a blinded, within-person randomised, paired validating clinical trial. From 2014 to 2016, 141 men who had undergone a prior (positive or negative) transrectal ultrasound biopsy and had a discrete lesion on mpMRI (score 3-5) requiring targeted transperineal biopsy were enrolled at a UK academic hospital; 129 underwent both biopsy strategies and completed the study.

interventionThe order of performing biopsies using visual registration and a computer-assisted MRI/ultrasound image-fusion system (SmartTarget) on each patient was randomised. The equipment was reset between biopsy strategies to mitigate incorporation bias. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The proportion of clinically significant prostate cancer (primary outcome: Gleason pattern ≥3+4=7, maximum cancer core length ≥4mm; secondary outcome: Gleason pattern ≥4+3=7, maximum cancer core length ≥6mm) detected by each method was compared using McNemar's test of paired proportions. RESULTS AND LIMITATIONS: The two strategies combined detected 93 clinically significant prostate cancers (72% of the cohort). Each strategy detected 80/93 (86%) of these cancers; each strategy identified 13 cases missed by the other. Three patients experienced adverse events related to biopsy (urinary retention, urinary tract infection, nausea, and vomiting). No difference in urinary symptoms, erectile function, or quality of life between baseline and follow-up (median 10.5 wk) was observed. The key limitations were lack of parallel-group randomisation and a limit on the number of targeted cores.

conclusionsVisual-registration and image-fusion targeting strategies combined had the highest detection rate for clinically significant cancers. Targeted prostate biopsy should be performed using both strategies together. PATIENT SUMMARY: We compared two prostate cancer biopsy strategies: visual registration and image fusion. A combination of the two strategies found the most clinically important cancers and should be used together whenever targeted biopsy is being performed.

Indexed as

Magnetic Resonance ImagingMultimodal ImagingUltrasonographyAgedFalse Negative ReactionsHumansImage-Guided BiopsyMaleMiddle AgedNeoplasm GradingProspective StudiesProstatic NeoplasmsRisk AssessmentSingle-Blind MethodBiopsyDiagnostic imagingProstatic neoplasms

Identifiers

PMID30527787
PMCPMC6469539

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.