Evidence map›Paper›PMID 36879271›Full record

ArticleTrials2023

DEPROMP Trial: the additive value of PSMA-PET/CT-guided biopsy for prostate cancer management in biopsy naïve men-study protocol for a randomized trial.

P Krausewitz, R A Bundschuh, F C Gaertner, M Essler, U Attenberger, J Luetkens, G Kristiansen, M Muders, C-H Ohlmann, S Hauser and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% of its field
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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. 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

12 authors at 2 institutions in 1 country.

P KrausewitzDepartment of Urology and Pediatric Urology, University Hospital Bonn, Bonn, Germany. philipp.krausewitz@ukbonn.de.ORCID http://orcid.org/0000-0002-8213-9975
R A BundschuhDepartment of Nuclear Medicine, University Hospital Bonn, Bonn, Germany.
F C GaertnerDepartment of Nuclear Medicine, University Hospital Bonn, Bonn, Germany.
M EsslerDepartment of Nuclear Medicine, University Hospital Bonn, Bonn, Germany.
U AttenbergerDepartment of Diagnostic and Interventional Radiology, University Hospital Bonn, Bonn, Germany.
J LuetkensDepartment of Diagnostic and Interventional Radiology, University Hospital Bonn, Bonn, Germany.
G KristiansenInstitute of Pathology, University Hospital Bonn, Bonn, Germany.
M MudersInstitute of Pathology, University Hospital Bonn, Bonn, Germany.
C-H OhlmannDepartment of Urology, Johanniter Hospital Bonn, Bonn, Germany.
S HauserDepartment of Urology and Pediatric Urology, University Hospital Bonn, Bonn, Germany.
J EllingerDepartment of Urology and Pediatric Urology, University Hospital Bonn, Bonn, Germany.
M RitterDepartment of Urology and Pediatric Urology, University Hospital Bonn, Bonn, Germany.
University Hospital Bonn · DEJohanniter-Krankenhaus Bonn · DE

Funding

Medizinische Fakultät, Rheinische Friedrich-Wilhelms-Universität Bonn 2019-FKS-07
6 · The paper itself

Abstract

backgroundThe primary objective is to determine the proportion of men with suspected prostate cancer (PCA) in whom the management plans are changed by additive gallium-68 prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA-PET/CT) guided prostate biopsy (PET-TB) in combination with standard of care (SOC) using systematic (SB) and multiparametric magnetic resonance imaging-guided biopsy (MR-TB) compared with SOC alone. The major secondary objectives are to determine the additive value of the combined approach of SB + MR-TB + PET-TB (PET/MR-TB) for detecting clinically significant PCA (csPCA) compared to SOC; to determine sensitivity, specificity, positive and negative predictive value and diagnostic accuracy of imaging techniques, respective imaging classification systems, and each biopsy method; and to compare preoperatively defined tumor burden and biomarker expression and pathological tumor extent in prostate specimens.

methodsThe DEPROMP study is a prospective, open-label, interventional investigator-initiated trial. Risk stratification and management plans after PET/MR-TB are conducted randomized and blinded by different evaluation teams of experienced urologists based on histopathological analysis and imaging information: one including all results of the PET/MR-TB and one excluding the additional information gained by PSMA-PET/CT guided biopsy. The power calculation was centered on pilot data, and we will recruit up to 230 biopsy-naïve men who will undergo PET/MR-TB for suspected PCA. Conduct and reporting of MRI and PSMA-PET/CT will be performed in a blinded fashion. DISCUSSION: The DEPROMP Trial will be the first to evaluate the clinically relevant effects of the use of PSMA-PET/CT in patients with suspected PCA compared to current SOC. The study will provide prospective data to determine the diagnostic yields of additional PET-TB in men with suspected PCA and the impact on treatment plans in terms of intra- and intermodal changes. The results will allow a comparative analysis of risk stratification by each biopsy method, including a performance analysis of the corresponding rating systems. This will reveal potential intermethod and pre- and postoperative discordances of tumor stage and grading, providing the opportunity to critically assess the need for multiple biopsies.

trial registrationGerman Clinical Study Register DRKS 00024134. Registered on 26 January 2021.

Indexed as

Positron Emission Tomography Computed TomographyProstatic NeoplasmsHumansImage-Guided BiopsyMalePositron-Emission TomographyProspective StudiesRandomized Controlled Trials as TopicClinically significant prostate cancerManagement planMultiparametric MRIProstate biopsyPSMA-PET/CT

Identifiers

PMID36879271
PMCPMC9987083
OpenAlexW4323317447

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.