Evidence map›Paper›PMID 35379264›Full record

Trial reportRadiation oncology (London, England)2022

A phase II trial of stereotactic body radiotherapy in 4 fractions for patients with localized prostate cancer.

S Kawakami, H Tsumura, T Satoh, K Tabata, A Sekiguchi, T Kainuma, M Nakano, M Iwamura, H Ishiyama

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Radiation oncology (London, England), 2022. 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
–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

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. 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

9 authors.

S KawakamiDepartment of Radiation Oncology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minamiku, Sagamihara, Japan.
H TsumuraDepartment of Urology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minamiku, Sagamihara, Japan.
T SatohDepartment of Urology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minamiku, Sagamihara, Japan.
K TabataDepartment of Urology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minamiku, Sagamihara, Japan.
A SekiguchiDepartment of Radiation Oncology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minamiku, Sagamihara, Japan.
T KainumaDepartment of Radiation Oncology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minamiku, Sagamihara, Japan.
M NakanoDepartment of Radiation Oncology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minamiku, Sagamihara, Japan.
M IwamuraDepartment of Urology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minamiku, Sagamihara, Japan.
H IshiyamaDepartment of Radiation Oncology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minamiku, Sagamihara, Japan. hishiyam@kitasato-u.ac.jp.ORCID http://orcid.org/0000-0001-7907-8422

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PURPOSE/OBJECTIVE(S): To report results from our phase II study of stereotactic body radiotherapy (SBRT) delivering 36 Gy in 4 fractions for patients with localized prostate cancer. MATERIALS/

methodsWe enrolled 55 patients treated with SBRT delivering 36 Gy in 4 fractions between 2015 to 2018. All patients were categorized as low-risk (n = 4), intermediate-risk (n = 31) or high-risk (n = 20) according to National Comprehensive Cancer Network criteria. Median age was 73 years (range 54-86 years). Two-thirds of patients (n = 37) had received androgen-deprivation therapy for 3-46 months (median, 31 months). Median duration of follow-up was 36 months (range 1-54 months). We used Radiation Therapy Oncology Group and National Cancer Institute-Common Toxicity Criteria version 4 for toxicity assessments. Quality of life (QOL) outcomes were also evaluated using the Expanded Prostate Cancer Index Composite (EPIC).

resultsProtocol treatments were completed for all patients. Six patients experienced biochemical failures. Among these six patients, three patients experienced clinical failure. One patient showed bone metastasis before biochemical failure. One patient died of gastric cancer. The 3-year biochemical control rate was 89.8%. Acute grade 2 genitourinary (GU) and gastrointestinal (GI) toxicities were observed in 5 patients (9%) and 6 patients (11%), respectively. No grade 3 or higher acute toxicities were observed. Late grade 2 GU and GI toxicities were observed in 7 patients (13%) and 4 patients (7%), respectively. Late grade 3 GU and GI toxicities were observed in 1 patient (1.8%) each. EPIC scores decreased slightly during the acute phase and recovered within 3 months after treatment.

conclusionOur phase II study showed that SBRT delivering 36 Gy in 4 fractions was safe and effective with favorable QOL outcomes, although this regimen showed slightly more severe toxicities compared to current standards.

Indexed as

Prostatic NeoplasmsRadiosurgeryAgedAged, 80 and overAndrogen AntagonistsHumansMaleMiddle AgedQuality of LifeUrogenital SystemAndrogen Antagonists

Identifiers

PMID35379264
PMCPMC8978412

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.