Evidence map›Paper›PMID 30180867›Full record

ArticleRadiation oncology (London, England)2018

ONE SHOT - single shot radiotherapy for localized prostate cancer: study protocol of a single arm, multicenter phase I/II trial.

Thomas Zilli, Marta Scorsetti, Daniel Zwahlen, Ciro Franzese, Robert Förster, Niccolò Giaj-Levra, Nikolaos Koutsouvelis, Aurelie Bertaut, Michel Zimmermann, Giuseppe Roberto D'Agostino and 3 more

Erratum issued Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Radiation oncology (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03294889 (ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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.

NCT03294889 phase1 / phase2recruitingnot on this map

ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial

TypeinterventionalSponsorUniversity Hospital, GenevaRan2017 to 2030Enrolled45ConditionsProstate CancerArmsStereotactic body radition (SBRT)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Thomas ZilliRadiation Oncology, Geneva University Hospital, CH-1211, 14, Geneva, Switzerland. Thomas.Zilli@hcuge.ch.ORCID http://orcid.org/0000-0002-4784-9883
Marta ScorsettiRadiation Oncology, Humanitas University, Rozzano, Milan, Italy.
Daniel ZwahlenRadiation Oncology, Kantonsspital Graubünden, Chur, Switzerland.
Ciro FranzeseRadiation Oncology, Humanitas Research Hospital and Cancer Center, Rozzano, Milan, Italy.
Robert FörsterRadiation Oncology, University Hospital Zürich, Zürich, Switzerland.
Niccolò Giaj-LevraRadiation Oncology, Sacro Cuore Don-Calabria, Negrar, Italy.
Nikolaos KoutsouvelisRadiation Oncology, Geneva University Hospital, CH-1211, 14, Geneva, Switzerland.
Aurelie BertautMethodology and biostatistic unit, Centre Georges François Leclerc, Dijon, France.
Michel ZimmermannRadiation Oncology, Kantonsspital Graubünden, Chur, Switzerland.
Giuseppe Roberto D'AgostinoRadiation Oncology, Humanitas Research Hospital and Cancer Center, Rozzano, Milan, Italy.
Filippo AlongiRadiation Oncology, Sacro Cuore Don-Calabria, Negrar, Italy.
Matthias GuckenbergerRadiation Oncology, University Hospital Zürich, Zürich, Switzerland.
Raymond MiralbellRadiation Oncology, Geneva University Hospital, CH-1211, 14, Geneva, Switzerland.

Funding

Fondation pour la Lutte contre le Cancer et pour les Recherches Médico-Biologiques 2017
6 · The paper itself

Abstract

backgroundStereotactic body radiotherapy (SBRT) is an emerging treatment alternative for patients with localized prostate cancer. Promising results in terms of disease control and toxicity have been reported with 4 to 5 SBRT fractions. However, question of how far can the number of fractions with SBRT be reduced is a challenging research matter. As already explored by some authors in the context of brachytherapy, monotherapy appears to be feasible with an acceptable toxicity profile and a promising outcome. The aim of this multicenter phase I/II prospective trialis to demonstrate early evidence of safety and efficacy of a single-fraction SBRT approach for the treatment of localized disease.

methodsPatients with low- and intermediate-risk localized prostate cancer without significant tumor in the transitional zone will be treated with a single SBRT fraction of 19 Gy to the whole prostate gland with urethra-sparing (17 Gy). Intrafractional motion will be monitored with intraprostatic electromagnetic transponders. The primary endpoint of the phase I part of the study will be safety as assessed by CTCAE 4.03 grading scale, while biochemical relapse-free survival will be the endpoint for the phase II. The secondary endpoints include acute and late toxicity, quality of life, progression-free survival, and prostate-cancer specific survival. DISCUSSION: This is the first multicenter phase I/II trial assessing the efficacy and safety of a single-dose SBRT treatment for patients with localized prostate cancer. If positive, results of ONE SHOT may help to design subsequent phase III trials exploring the role of SBRT monotherapy in the exclusive radiotherapy treatment of localized disease.

trial registrationClinicaltrials.gov identifier: NCT03294889 ; Registered 27 September 2017.

Indexed as

Clinical Trials, Phase I as TopicClinical Trials, Phase II as TopicMulticenter Studies as TopicHumansMaleProspective StudiesProstate-Specific AntigenProstatic NeoplasmsQuality of LifeRadiosurgerySurvival AnalysisProstate-Specific AntigenElectromagnetic transpondersProstate cancerQuality of lifeSingle fractionStereotactic body radiotherapyUrethra-sparing

Identifiers

PMID30180867
PMCPMC6123974

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.