Evidence map›Paper›PMID 38218388›Full record

Trial reportUrology2024

A Phase II Prospective Blinded Trial of Magnetic Resonance Imaging and In-Bore Biopsy in Active Surveillance for Prostate Cancer.

Bjoern J Langbein, Brittany Berk, Camden Bay, Kemal Tuncali, Neil Martin, Martin Schostak, Fiona Fennessy, Clare Tempany, Adam S Kibel, Alexander P Cole

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Urology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Bjoern J LangbeinDepartment of Urology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Department of Urology, Urooncology, Robot-Assisted and Focal Therapy, University Hospital Magdeburg, Magdeburg, Germany.
Brittany BerkDepartment of Urology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Camden BayDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Kemal TuncaliDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Neil MartinDana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Department of Radiation Oncology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Martin SchostakDepartment of Urology, Urooncology, Robot-Assisted and Focal Therapy, University Hospital Magdeburg, Magdeburg, Germany.
Fiona FennessyDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.
Clare TempanyDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Adam S KibelDepartment of Urology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Alexander P ColeDepartment of Urology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, MA. Electronic address: apcole@bwh.harvard.edu.

Funding

Image Guided Therapy Center - Ultrasound-based sensor system for the monitoring of COVID-19 patientsP41EB015898 · NIBIB · BRIGHAM AND WOMEN'S HOSPITAL · PI TEMPANY, CLARE M · 2012 to 2021
$18.9M
TRD 3 - Enabling Technologies for Intraprocedural GuidanceP41EB028741 · NIBIB · BRIGHAM AND WOMEN'S HOSPITAL · PI Carl-Fredrik Westin · 2021 to 2026
$10.7M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
Pilot study of an implantable microdevice to test multiple drug responses in prostate cancer patientsR01CA232174 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI HATA, NOBUHIKO, JONAS, OLIVER · 2019 to 2023
$3.4M
Training in Image Guidance, Precision Diagnosis and TherapyT32EB025823 · NIBIB · BRIGHAM AND WOMEN'S HOSPITAL · PI Fiona Fennessy, Lauren Jean O'Donnell · 2019 to 2026
$1.5M
NCI NIH HHS R01 CA232174NCI NIH HHS UG1 CA233180NIBIB NIH HHS P41 EB015898NIBIB NIH HHS P41 EB028741NIBIB NIH HHS T32 EB025823
6 · The paper itself

Abstract

objectiveTo demonstrate the added benefit of multiparametric (mp)MRI risk stratification during active surveillance.

methodsThis prospective, single-arm, nonrandomized study included 82 men with low-risk prostate cancer (PCa). We compared two biopsy strategies in parallel. The first biopsy strategy was an in-bore and transrectal ultrasound (TRUS) biopsy in men with suspicious mpMRI findings. The second was a TRUS biopsy in all 82 men, blinded to the results of the previously performed mpMRI.

resultsWe identified 27/82 men with suspicious mpMRI. Of those 27 men, we detected 8/27 with csPCa on biopsy, and we identified two men with in-bore biopsy exclusively, three men with TRUS biopsy exclusively, and three men with both biopsy strategies. Of the 55/82 men with nonsuspicious mpMRI (who only received TRUS biopsies), two men had csPCa. TRUS biopsy of the entire cohort of 82 men would have led to the correct diagnosis of 80% men with csPCa, requiring all 82 men to receive biopsies (csPCa in 10% of the 82 biopsies). Conducting in-bore biopsies plus TRUS biopsies in men with suspicious mpMRI would have also led to the detection of 80% of men with csPCa, requiring only 27 men to receive biopsies (csPCa in 30% of the 27 biopsies).

conclusionThe combination of TRUS and in-bore biopsies, limited to men with suspicious mpMRI, resulted in a similar detection rate of csPCa compared to TRUS biopsies of all men but required only one-third of men to undergo biopsy. Our results indicate that in-bore and TRUS biopsies continue to complement each other.

Indexed as

Prostatic NeoplasmsWatchful WaitingBiopsyHumansImage-Guided BiopsyMagnetic Resonance ImagingMaleProspective StudiesUltrasonography, Interventional

Identifiers

PMID38218388
PMCPMC11161128

What OpenQuestion holds

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Registered trials

None linked

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.