Evidence map›Paper›PMID 31291969›Full record

Trial reportRadiation oncology (London, England)2019

Prostate bed irradiation with alternative radio-oncological approaches (PAROS) - a prospective, multicenter and randomized phase III trial.

Stefan A Koerber, Sonja Katayama, Anja Sander, Cornelia Jaekel, Matthias F Haefner, Juergen Debus, Klaus Herfarth

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Radiation oncology (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04831970 (POst-Prostatectomy Ablative Radiation Therapy), which is not on this 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
1.6field-weighted citation impact, top 16% 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.

NCT04831970 recruitingnot on this mapstarted 2021, after this paper: background citation

POst-Prostatectomy Ablative Radiation Therapy

TypeobservationalSponsorUniversity of Milano BicoccaRan2021 to 2026Enrolled30ConditionsRadiation Toxicity
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Guideline
  2. Article
  3. ACR-ARS Practice Parameter for the Performance of Proton Beam Therapy.International journal of particle therapy · 2024
    Article
  4. Article
  5. Article
  6. The history of ion beam therapy in Germany.Zeitschrift fur medizinische Physik · 2022
    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

7 authors at 4 institutions in 1 country.

Stefan A KoerberDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany. Stefan.Koerber@med.uni-heidelberg.de.
Sonja KatayamaDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Anja SanderInstitute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Germany.
Cornelia JaekelDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Matthias F HaefnerDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Juergen DebusDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Klaus HerfarthDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg University · DENational Center for Tumor Diseases · DEUniversity Hospital Heidelberg · DEZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFor patients with treatment-naïve carcinoma of the prostate, hypofractionated irradiation becomes more and more popular. Due to the low α/β value of prostate cancer, increased single dose leading to a shortened treatment period seems to be safe and feasible. However, reliable data is lacking for post-prostatectomy patients so far. Further, the role of proton therapy is still under debate. Two prospective phase II trials with both, hypofractionated photon and proton therapy, provided promising results. METHODS/

designThe PAROS trial is a prospective, multicenter and randomized phase III trial for men with localized prostate carcinoma after surgery. Post-prostatectomy patients will be randomized to either normofractionated radiotherapy (nRT) with photons (70.0/ 2.0 Gy), or hypofractionated radiotherapy (hRT) with photons (57.0/ 3.0 Gy) or hRT with protons (57.0/ 3.0 Gy relative biological effectiveness [RBE]). Block randomization is stratified by Gleason Score (≤ 7 vs. > 7) and treatment indication (adjuvant vs. salvage). The trial is planned to enroll 897 patients. The primary objective is to show an improvement in the bowel-score according to EORTC QLQ-PR25 after proton therapy compared to photon irradiation (week 12 vs. baseline). Secondary aims are non-inferiority of hRT compared to nRT with regard to biochemical progression-free survival (bPFS), overall survival (OS), quality of life and toxicity. DISCUSSION: The present study aims to evaluate the role of hypofractionated radiotherapy to the prostate bed with photons and protons leading to significant impact on future management of operated men with prostate cancer.

trial registrationDeutsches Register klinischer Studien: DRKS00015231 ; registered 27 September 2018.

Indexed as

Quality of LifeHumansMalePrognosisProspective StudiesProstatic NeoplasmsProton TherapyRadiation Dose HypofractionationRadiotherapy DosageRadiotherapy Planning, Computer-AssistedHypofractionationProstate bedProstate cancerProtonsRadiotherapySalvage

Identifiers

PMID31291969
PMCPMC6617634
OpenAlexW2958995476

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.