Evidence map›Paper›PMID 38630382›Full record

Trial reportInternational journal of clinical oncology2024

A Japanese multi-institutional phase II study of moderate hypofractionated intensity-modulated radiotherapy with image-guided technique for prostate cancer.

Katsumasa Nakamura, Keiji Nihei, Yoshihiro Saito, Naoto Shikama, Shin-Ei Noda, Ryusuke Hara, Toshiyuki Imagumbai, Takashi Mizowaki, Takeshi Akiba, Etsuo Kunieda and 10 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

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

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

  1. Pooled it
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  6. Review
  7. Observational
  8. Article
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  13. Linear accelerator selection: impact on feasibility dose-volume histograms and practicality in dose reduction for organs at risk during prostate volumetric-modulated arc therapy.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2025
    Article
  14. 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

20 authors.

Katsumasa NakamuraDepartment of Radiation Oncology, Hamamatsu University School of Medicine, Handayama 1-20-1, Higashi-ku, Hamamatsu, 431-3192, Japan. nakam@hama-med.ac.jp.ORCID http://orcid.org/0000-0003-2090-881X
Keiji NiheiOsaka Medical and Pharmaceutical University, Osaka, Japan.
Yoshihiro SaitoSaitama Cancer Center, Saitama, Japan.
Naoto ShikamaGraduate School of Medicine, Juntendo University, Tokyo, Japan.
Shin-Ei NodaInternational Medical Center, Saitama Medical University, Saitama, Japan.
Ryusuke HaraChiba Cancer Centre, Chiba, Japan.
Toshiyuki ImagumbaiKobe City Medical Center General Hospital, Hyogo, Japan.
Takashi MizowakiKyoto University, Kyoto, Japan.
Takeshi AkibaTokai University School of Medicine, Kanagawa, Japan.
Etsuo KuniedaTokai University School of Medicine, Kanagawa, Japan.
Masanori SomeyaSapporo Medical University School of Medicine, Sapporo, Japan.
Saiji OhgaKyushu Medical Center, Fukuoka, Japan.
Jiro KawamoriSt. Luke's International Hospital, Tokyo, Japan.
Takuyo KozukaToranomon Hospital, Tokyo, Japan.
Yosuke OtaHyogo Cancer Center, Hyogo, Japan.
Koji InabaNational Cancer Center Hospital, Tokyo, Japan.
Takeshi KodairaAichi Cancer Center Hospital, Aichi, Japan.
Yoshiyuki ItohAnjo Kosei Hospital, Aichi, Japan.
Kouta FunakoshiKyushu University Hospital, Fukuoka, Japan.
Yoshikazu KagamiShowa University School of Medicine, Tokyo, Japan.

Funding

Health Labor Sciences Research Grant H24-ganrinsho-ippan-007
6 · The paper itself

Abstract

backgroundThe aim of this multi-institutional phase II study was to confirm the safety and the potential efficacy of moderately hypofractionated intensity-modulated radiotherapy (IMRT) with prostate-based image-guidance for Japanese patients.

methodsPatients with low- or intermediate-risk localized prostate cancer were eligible. Patients with a part of high risk (having only one of the following factors, cT3a, 20 < PSA ≤ 30, or GS = 8 or 9) were also included. Hypofractionated IMRT using daily image-guided technique with prostate matching was performed with a total dose of 70 Gy in 28 fractions. Neoadjuvant hormonal therapy for 4-8 months was mandatory for patients with intermediate or high-risk prostate cancer.

resultsFrom 20 institutions, 134 patients enrolled. The median follow-up was 5.16 years (range, 1.43-6.47 years). The number of patients with low, intermediate, and high-risk prostate cancer was 20, 80, and 34, respectively. The 5-year overall, biochemical failure-free, and clinical failure-free survival was 94.5%, 96.0%, and 99.2%, respectively. The 5-year biochemical failure-free survival for patients with low-, intermediate-, and high-risk disease was 94.1%, 97.4%, and 93.9%, respectively. The incidences of grade 2 gastrointestinal (GI) and genitourinary (GU) late toxicities at 5 years were 5.3% and 5.3%, respectively. There are no acute or late toxicities ≥ grade 3. Of 124 patients who were followed for up to 5 years, the grade 2 late GU or GI toxicities were 10.5% (90% confidence intervals, 6.3-16.2%, p = 0.0958).

conclusionThe safety and efficacy of moderately hypofractionated IMRT with prostate-based image-guidance was confirmed among Japanese patients with prostate cancer.

Indexed as

Prostatic NeoplasmsRadiation Dose HypofractionationRadiotherapy, Image-GuidedRadiotherapy, Intensity-ModulatedAgedAged, 80 and overEast Asian PeopleHumansJapanMaleMiddle AgedExternal beam radiotherapyModerate hypofractionationProstate cancer

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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.