Evidence map›Paper›PMID 38560429›Full record

ArticleAdvances in radiation oncology2024

A Single-Institution Prospective Study To Evaluate the Safety and Efficacy of Real- Time Image-Gated Spot-Scanning Proton Therapy (RGPT) for Prostate Cancer.

Kentaro Nishioka, Takayuki Hashimoto, Takashi Mori, Yusuke Uchinami, Rumiko Kinoshita, Norio Katoh, Hiroshi Taguchi, Koichi Yasuda, Yoichi M Ito, Seishin Takao and 5 more

Open access · goldAbstract read
In one paragraph

Article in Advances in radiation oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 28% 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.

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

5 citing papers in PubMed, 2 citations in OpenAlex.

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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

15 authors at 3 institutions in 1 country.

Kentaro NishiokaRadiation Oncology Division, Global Center for Biomedical Science and Engineering, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Takayuki HashimotoRadiation Oncology Division, Global Center for Biomedical Science and Engineering, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Takashi MoriDepartment of Radiation Oncology, Hokkaido University Hospital, Sapporo, Japan.
Yusuke UchinamiDepartment of Radiation Oncology, Hokkaido University Hospital, Sapporo, Japan.
Rumiko KinoshitaDepartment of Radiation Oncology, Hokkaido University Hospital, Sapporo, Japan.
Norio KatohDepartment of Radiation Oncology, Hokkaido University Faculty of Medicine, Sapporo, Japan.
Hiroshi TaguchiDepartment of Radiation Oncology, Hokkaido University Hospital, Sapporo, Japan.
Koichi YasudaDepartment of Radiation Oncology, Hokkaido University Hospital, Sapporo, Japan.
Yoichi M ItoData Science Center, Promotion Unit, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, Sapporo, Japan.
Seishin TakaoProton Beam Therapy Center, Hokkaido University Hospital, Sapporo, Japan.
Masaya TamuraProton Beam Therapy Center, Hokkaido University Hospital, Sapporo, Japan.
Taeko MatsuuraProton Beam Therapy Center, Hokkaido University Hospital, Sapporo, Japan.
Shinichi ShimizuDepartment of Carbon Ion Radiotherapy, Osaka University Graduate School of Medicine, Osaka, Japan.
Hiroki ShiratoRadiation Oncology Division, Global Center for Biomedical Science and Engineering, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Hidefumi AoyamaDepartment of Radiation Oncology, Hokkaido University Faculty of Medicine, Sapporo, Japan.
Hokkaido University Hospital · JPHokkaido University · JPThe University of Osaka · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: In real-time image-gated spot-scanning proton therapy (RGPT), the dose distribution is distorted by gold fiducial markers placed in the prostate. Distortion can be suppressed by using small markers and more than 2 fields, but additional fields may increase the dose to organs at risk. Therefore, we conducted a prospective study to evaluate the safety and short-term clinical outcome of RGPT for prostate cancer. Methods and Materials: Based on the previously reported frequency of early adverse events (AE) and the noninferiority margin of 10%, the required number of cases was calculated to be 43 using the one-sample binomial test by the Southwest Oncology Group statistical tools with the one-sided significance level of 2.5% and the power 80%. Patients with localized prostate cancer were enrolled and 3 to 4 pure gold fiducial markers of 1.5-mm diameter were inserted in the prostate. The prescribed dose was 70 Gy(relative biologic effectiveness) in 30 fractions, and treatment was performed with 3 fields from the left, right, and the back, or 4 fields from either side of slightly anterior and posterior oblique fields. The primary endpoint was the frequency of early AE (≥grade 2) and the secondary endpoint was the biochemical relapse-free survival rate and the frequency of late AE. Results: Forty-five cases were enrolled between 2015 and 2017, and all patients completed the treatment protocol. The median follow-up period was 63.0 months. The frequency of early AE (≥grade 2) was observed in 4 cases (8.9%), therefore the noninferiority was verified. The overall 5-year biochemical relapse-free survival rate was 88.9%. As late AE, grade 2 rectal bleeding was observed in 8 cases (17.8%). Conclusions: The RGPT for prostate cancer with 1.5-mm markers and 3- or 4- fields was as safe as conventional proton therapy in early AE, and its efficacy was comparable with previous studies.

Identifiers

PMID38560429
PMCPMC10981019
OpenAlexW4391649811

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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.