Evidence map›Paper›PMID 34953603›Full record

Trial reportEuropean urology2022

Patterns of Failure Following External Beam Radiotherapy With or Without an Additional Focal Boost in the Randomized Controlled FLAME Trial for Localized Prostate Cancer.

Veerle H Groen, Karin Haustermans, Floris J Pos, Cédric Draulans, Sofie Isebaert, Evelyn M Monninkhof, Robert J Smeenk, Martina Kunze-Busch, Johannes C J de Boer, Jochem van der Voort van Zijp and 2 more

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

Trial report in European urology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01168479 (FLAME), which is not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
7.2field-weighted citation impact, top 2% 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.

NCT01168479 phase3completednot on this map

FLAME: Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer

TypeinterventionalSponsorUMC UtrechtRan2009 to 2016Enrolled571ConditionsProstate Cancer, Radiotherapy, MRIArmsFLAME boost, standard arm
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 68 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 2 countries.

Veerle H GroenRadiation Oncology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Karin HaustermansRadiation Oncology, University Hospitals Leuven, Leuven, Belgium.
Floris J PosJulius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.
Cédric DraulansRadiation Oncology, University Hospitals Leuven, Leuven, Belgium.
Sofie IsebaertRadiation Oncology, University Hospitals Leuven, Leuven, Belgium.
Evelyn M MonninkhofJulius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.
Robert J SmeenkRadiation Oncology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Martina Kunze-BuschRadiation Oncology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Johannes C J de BoerRadiation Oncology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Jochem van der Voort van ZijpRadiation Oncology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Linda G W KerkmeijerRadiation Oncology, University Medical Centre Utrecht, Utrecht, The Netherlands; Radiation Oncology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Uulke A van der HeideRadiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: u.vd.heide@nki.nl.
University Medical Center Utrecht · NLKU Leuven · BERadboud University Nijmegen · NLRadboud University Medical Center · NLThe Netherlands Cancer Institute · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFocal dose escalation in external beam radiotherapy (EBRT) showed an increase in 5-yr biochemical disease-free survival in the Focal Lesion Ablative Microboost in Prostate Cancer (FLAME) trial.

objectiveTo analyze the effect of a focal boost to intraprostatic lesions on local failure-free survival (LFS) and regional + distant metastasis-free survival (rdMFS). DESIGN, SETTING, AND

participantsPatients with intermediate- or high-risk localized prostate cancer were included in FLAME, a phase 3, multicenter, randomized controlled trial.

interventionStandard treatment of 77 Gy to the entire prostate in 35 fractions was compared to an additional boost to the macroscopic tumor of up to 95 Gy during EBRT. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: LFS and rdMFS, measured via any type of imaging, were compared between the treatment arms using Kaplan-Meier and Cox regression analyses. Dose-response curves were created for local failure (LF) and regional + distant metastatic failure (rdMF) using logistic regression. RESULTS AND LIMITATIONS: A total of 571 patients were included in the FLAME trial. Over median follow-up of 72 mo (interquartile range 58-86), focal boosting decreased LF (hazard ratio [HR] 0.33, 95% confidence interval [CI] 0.14-0.78) and rdMF (HR 0.58, 95% CI 0.35-0.93). Dose-response curves showed that a greater dose to the tumor resulted in lower LF and rdMF rates.

conclusionsA clear dose-response relation for LF and rdMF was observed, suggesting that adequate focal dose escalation to intraprostatic lesions prevents undertreatment of the primary tumor, resulting in an improvement rdMF. PATIENT SUMMARY: Radiotherapy is a treatment option for high-risk prostate cancer. The FLAME trial has shown that a high dose specifically targeted at the tumor within the prostate will result in better disease outcome, with less likelihood of regional and distant disease spread. The FLAME trial is registered on ClinicalTrials.gov as NCT01168479.

Indexed as

BrachytherapyProstatic NeoplasmsDisease-Free SurvivalHumansMaleProportional Hazards ModelsRadiotherapy DosageDose-response analysisExternal beam radiotherapyFocal boostingPatterns of failure analysisProstate cancer

Identifiers

PMID34953603
OpenAlexW4200459022

What OpenQuestion holds

Textmetadata
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.