Evidence map›Paper›PMID 30545809›Full record

ArticleJMIR research protocols2018

Benefits of Elective Para-Aortic Radiotherapy for pN1 Prostate Cancer Using Arc Therapy (Intensity-Modulated or Volumetric Modulated Arc Therapy): Protocol for a Nonrandomized Phase II Trial.

Cédric Draulans, Steven Joniau, Valérie Fonteyne, Louke Delrue, Karel Decaestecker, Wouter Everaerts, Piet Dirix, Laura Van den Bergh, Wouter Crijns, Hans Vandendriessche and 7 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JMIR research protocols, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03079323 (Phase II Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.3field-weighted citation impact, top 19% 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.

NCT03079323 phase2unknown statusnot on this map

Phase II Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy (PART) for pN1 Prostate Cancer Using Arc Therapy (IMAT/VMAT)

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2017 to 2025Enrolled137ConditionsProstate CancerArmsPART-trial
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. 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 at 4 institutions in 1 country.

Cédric DraulansDepartment of Radiation Oncology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-1267-7874
Steven JoniauDepartment of Urology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0003-3195-9890
Valérie FonteyneDepartment of Radiation Oncology, Ghent University Hospital, University of Ghent, Ghent, Belgium.ORCID http://orcid.org/0000-0001-6724-1595
Louke DelrueDepartment of Radiology, Ghent University Hospital, University of Ghent, Ghent, Belgium.ORCID http://orcid.org/0000-0002-4047-1312
Karel DecaesteckerDepartment of Urology, Ghent University Hospital, University of Ghent, Ghent, Belgium.ORCID http://orcid.org/0000-0003-0767-940X
Wouter EveraertsDepartment of Urology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-3157-7115
Piet DirixDepartment of Radiation Oncology, Iridium Cancer Network, Wilrijk, Antwerp, Belgium.ORCID http://orcid.org/0000-0002-1278-1903
Laura Van den BerghDepartment of Radiation Oncology, Limburg Oncology Centre, Hasselt, Belgium.ORCID http://orcid.org/0000-0001-6598-1493
Wouter CrijnsDepartment of Radiation Oncology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-2894-3110
Hans VandendriesscheDepartment of Urology, AZ Jan Portaels, Vilvoorde, Belgium.ORCID http://orcid.org/0000-0002-7495-227X
Lodewijk Van WynsbergeDepartment of Urology, General Regional Hospital Tienen, Tienen, Belgium.ORCID http://orcid.org/0000-0002-7926-1179
Piet OstDepartment of Radiation Oncology, Ghent University Hospital, University of Ghent, Ghent, Belgium.ORCID http://orcid.org/0000-0002-2203-4848
Nicolaas LumenDepartment of Urology, Ghent University Hospital, University of Ghent, Ghent, Belgium.ORCID http://orcid.org/0000-0003-1242-3644
Pieterjan BuelensDepartment of Radiation Oncology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0003-0811-518X
Karin HaustermansDepartment of Radiation Oncology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0003-0364-682X
Charlien BerghenDepartment of Radiation Oncology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0001-9661-1436
Gert De MeerleerDepartment of Radiation Oncology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-2891-6235
KU Leuven · BEGhent University Hospital · BEAZ Sint-Jan · BEIridium Kankernetwerk · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with prostate cancer (PCa) with histopathologically proven pelvic lymph node (LN) metastasis (pN1) after extended pelvic lymph node dissection (ePLND), multimodality treatment consisting of treatment of the primary tumor and whole pelvic radiotherapy (WPRT) combined with androgen deprivation therapy (ADT) offers promising results, leading to better cause-specific survival rates compared with ADT alone. However, in case more than one pelvic LN is invaded by the tumor, approximately 40% of the patients relapse biochemically and clinically. Clinical relapse is present in the para-aortic LNs (M1a disease) in up to 77% of the relapsing cases.

objectiveWe hypothesize that, based on the evidence that positive LNs represent the door to hematogenous dissemination, elective para-aortic irradiation will reduce the development of both retroperitoneal nodal (M1a) and distant metastasis (M1b or M1c disease), postpone the need for palliative ADT, and prolong the time to castration-refractory disease.

methodsTo test this hypothesis, we will conduct a prospective, nonrandomized phase II trial to study the efficacy of additional elective para-aortic radiotherapy (PART) in pN1 patients compared with those who were historically treated with adjuvant WPRT alone. We aim to include 137 patients with PCa and presence of pN1 disease after ePLND. With this number of patients, an improvement of 15% in the 5-year clinical relapse-free survival can be detected with a power of 80%.

resultsRecruitment of patients for this trial started in 2017 and will be completed approximately by March 2020.

conclusionsThis is the first phase II trial to investigate the benefits of an elective PART in patients with PCa. The results of this trial will potentially serve as a sound base for a later randomized phase III trial. All participants are given a PART information sheet and required to give written informed consent. Results are expected to be published in a peer-reviewed journal.

trial registrationClinicalTrials.gov NCT03079323; https://clinicaltrials.gov/ct2/show/NCT03079323 (Archived by WebCite at http://www.webcitation.org/73ELimv1d). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/11256.

Indexed as

elective para-aortic radiotherapyexternal beam radiotherapyPART trialprostate cancer

Identifiers

PMID30545809
PMCPMC6315267
OpenAlexW2886740747

What OpenQuestion holds

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LicenceCC BY
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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.