Evidence map›Paper›PMID 29943185›Full record

Trial reportEuropean radiology2019

Twelve-month prostate volume reduction after MRI-guided transurethral ultrasound ablation of the prostate.

David Bonekamp, M B Wolf, M C Roethke, S Pahernik, B A Hadaschik, G Hatiboglu, T H Kuru, I V Popeneciu, J L Chin, M Billia and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European radiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06223295 (Effectiveness of Focal Therapy in Men With Prostate Cancer), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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.

NCT06223295 narecruitingnot on this mapstarted 2024, after this paper: background citation

Effectiveness of Focal Therapy in Men With Prostate Cancer

TypeinterventionalSponsorRadboud University Medical CenterRan2024 to 2031Enrolled356ConditionsProstate Cancer, Prostate NeoplasmArmsFocal therapy, Usual care
3 · Its place in the literature

Who cites it

21 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Treatment Planning Strategies for Interstitial Ultrasound Ablation of Prostate Cancer.IEEE open journal of engineering in medicine and biology · 2024
    Article
  6. Article
  7. Article
  8. The use of advanced imaging in guiding the further investigation and treatment of primary prostate cancer.Cancer imaging : the official publication of the International Cancer Imaging Society · 2022
    Review
  9. Review
  10. Review
  11. Review
  12. Image-Guided High-Intensity Focused Ultrasound, A Novel Application for Interventional Nuclear Medicine?Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2021
    Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

17 authors.

David BonekampDepartment of Radiology (E010), German Cancer Research Center (DKFZ), Im Neuenheimer Feld 280, 69120, Heidelberg, Germany. d.bonekamp@dkfz-heidelberg.de.ORCID http://orcid.org/0000-0002-4811-0087
M B WolfDepartment of Radiology (E010), German Cancer Research Center (DKFZ), Im Neuenheimer Feld 280, 69120, Heidelberg, Germany.
M C RoethkeDepartment of Radiology (E010), German Cancer Research Center (DKFZ), Im Neuenheimer Feld 280, 69120, Heidelberg, Germany.
S PahernikDepartment of Urology, University Hospital Heidelberg, Heidelberg, Germany.
B A HadaschikDepartment of Urology, University Hospital Heidelberg, Heidelberg, Germany.
G HatibogluDepartment of Urology, University Hospital Heidelberg, Heidelberg, Germany.
T H KuruDepartment of Urology, University Hospital Heidelberg, Heidelberg, Germany.
I V PopeneciuDepartment of Urology, University Hospital Heidelberg, Heidelberg, Germany.
J L ChinDepartment of Urology, University of Western Ontario (UWO), London Health Sciences Center, Victoria Hospital, London, ON, Canada.
M BilliaDepartment of Urology, University of Western Ontario (UWO), London Health Sciences Center, Victoria Hospital, London, ON, Canada.
J RelleDepartment of Urology, Beaumont Health System, Royal Oak, MI, USA.
J HafronDepartment of Urology, Beaumont Health System, Royal Oak, MI, USA.
K R NandalurDepartment of Radiology, Beaumont Health System, Royal Oak, MI, USA.
R M StaruchClinical Science, Profound Medical Inc., Toronto, ON, Canada.
M BurtnykClinical Science, Profound Medical Inc., Toronto, ON, Canada.
M HohenfellnerDepartment of Urology, University Hospital Heidelberg, Heidelberg, Germany.
H-P SchlemmerDepartment of Radiology (E010), German Cancer Research Center (DKFZ), Im Neuenheimer Feld 280, 69120, Heidelberg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo quantitatively assess 12-month prostate volume (PV) reduction based on T2-weighted MRI and immediate post-treatment contrast-enhanced MRI non-perfused volume (NPV), and to compare measurements with predictions of acute and delayed ablation volumes based on MR-thermometry (MR-t), in a central radiology review of the Phase I clinical trial of MRI-guided transurethral ultrasound ablation (TULSA) in patients with localized prostate cancer. MATERIALS AND

methodsTreatment day MRI and 12-month follow-up MRI and biopsy were available for central radiology review in 29 of 30 patients from the published institutional review board-approved, prospective, multi-centre, single-arm Phase I clinical trial of TULSA. Viable PV at 12 months was measured as the remaining PV on T2-weighted MRI, less 12-month NPV, scaled by the fraction of fibrosis in 12-month biopsy cores. Reduction of viable PV was compared to predictions based on the fraction of the prostate covered by the MR-t derived acute thermal ablation volume (ATAV, 55°C isotherm), delayed thermal ablation volume (DTAV, 240 cumulative equivalent minutes at 43°C thermal dose isocontour) and treatment-day NPV. We also report linear and volumetric comparisons between metrics.

resultsAfter TULSA, the median 12-month reduction in viable PV was 88%. DTAV predicted a reduction of 90%. Treatment day NPV predicted only 53% volume reduction, and underestimated ATAV and DTAV by 36% and 51%.

conclusionQuantitative volumetry of the TULSA phase I MR and biopsy data identifies DTAV (240 CEM43 thermal dose boundary) as a useful predictor of viable prostate tissue reduction at 12 months. Immediate post-treatment NPV underestimates tissue ablation. KEY POINTS: • MRI-guided transurethral ultrasound ablation (TULSA) achieved an 88% reduction of viable prostate tissue volume at 12 months, in excellent agreement with expectation from thermal dose calculations. • Non-perfused volume on immediate post-treatment contrast-enhanced MRI represents only 64% of the acute thermal ablation volume (ATAV), and reports only 60% (53% instead of 88% achieved) of the reduction in viable prostate tissue volume at 12 months. • MR-thermometry-based predictions of 12-month prostate volume reduction based on 240 cumulative equivalent minute thermal dose volume are in excellent agreement with reduction in viable prostate tissue volume measured on pre- and 12-month post-treatment T2w-MRI.

Indexed as

AgedBiopsy, Large-Core NeedleFollow-Up StudiesHigh-Intensity Focused Ultrasound AblationHumansMagnetic Resonance ImagingMaleMiddle AgedOrgan SizeProspective StudiesProstatic NeoplasmsTime FactorsTransurethral Resection of ProstateTreatment OutcomeBiopsy, needleHigh-intensity focused ultrasound ablationInterventional magnetic resonance imagingProstate cancerThermometry

Identifiers

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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.