Evidence map›Paper›PMID 39182931›Full record

ArticleBMJ open2024

Two-fractionated stereotactic magnetic resonance-guided adaptive radiation therapy for patients with prostate cancer (SMART PRO trial): protocol for a confirmatory clinical trial.

Sadamoto Zenda, Tairo Kashihara, Tetsuo Saito, Hiroyuki Okamoto, Noriyuki Kadoya, Takahiro Chiba, Shin-Ei Noda, Takashi Kawaguchi, Keiichi Jingu, Keiko Shibuya and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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

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

1 citing paper in PubMed.

  1. Magnetic resonance-guided adaptive stereotactic radiotherapy in prostate cancer patients: a systematic literature review.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2025
    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.

Sadamoto ZendaDepartment of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-0421-5805
Tairo KashiharaDepartment of Radiation Oncology, National Cancer Center Hospital, Chuo-ku, Japan tkashiha@ncc.go.jp.
Tetsuo SaitoDivision of Integrative Medical Oncology, Saiseikai Kumamoto Hospital, Kumamoto-Shi, Kumamoto, Japan.
Hiroyuki OkamotoDepartment of Radiation Oncology, National Cancer Center Hospital, Chuo-ku, Japan.
Noriyuki KadoyaDepartment of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Takahiro ChibaDepartment of Radiation Oncology, National Cancer Center Hospital, Chuo-ku, Japan.
Shin-Ei NodaDepartment of Radiation Oncology, Saitama Medical University, Iruma-gun, Japan.
Takashi KawaguchiDepartment of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, Hachioji, Japan.ORCID 0000-0003-2446-7716
Keiichi JinguDepartment of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Keiko ShibuyaDepartment of Radiation Oncology, Osaka Metropolitan University Graduate School of Medicine School of Medicine, Osaka, Japan.
Takashi UnoDiagnostic Radiology and Radiation Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Hiroshi IgakiDepartment of Radiation Oncology, National Cancer Center Hospital, Chuo-ku, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn an MRI-guided linear accelerator (MR-LINAC) system, the planned doses for organs at risk and for tumours are assessed by MR imaging and re-contouring at every treatment. This allows treatment to be safer and more precise by ensuring that it is suitable for the state of the patient's organs on that day, as well as by allowing images to be acquired during radiation therapy to prevent radiation while organs are in motion.Here, we will conduct a confirmatory study of two-fractionated stereotactic magnetic resonance-guided adaptive radiation therapy for patients with localised prostate cancer. METHODS AND ANALYSIS: This will be a single-arm study to demonstrate the safety and efficacy of ultra-hypofractionated radiation (26 Gy/2 Fr) using an MR-LINAC system in patients with very low-intermediate risk prostate cancer.The primary endpoint will be the incidence of grade ≥2 acute urinary tract adverse events occurring within 90 days of the start of radiation therapy.The sample size has been determined to be 58. ETHICS AND DISSEMINATION: This study is performed in accordance with Ethical Guidelines for Medical and Health Research Involving Human Subjects, published by Japan's Ministry of Education, Science and Technology and the Ministry of Health, Labour and Welfare and the modified act on the Protection of Personal Information as well as the Declaration of Helsinki. This study was approved by the institutional ethics committee of the National Cancer Center on 20 November 2021.The findings of this trial will be submitted to an international peer-reviewed journal and the key findings will be presented at an international scientific conference.Authorship will be ascribed in accordance with the International Committee of Medical Journal Editors guidance. TRIAL REGISTRATION NUMBER: UMIN000049746.

Indexed as

Prostatic NeoplasmsRadiotherapy, Image-GuidedDose Fractionation, RadiationHumansMagnetic Resonance ImagingMaleRadiation Dose HypofractionationRadiosurgeryMagnetic resonance imagingProstate diseaseQuality of LifeRadiation oncologySafety

Identifiers

PMID39182931
PMCPMC11404251

What OpenQuestion holds

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Registered trials

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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.