Evidence map›Paper›PMID 34674739›Full record

ArticleTrials2021

Salvage hypofractionated accelerated versus standard radiotherapy for the treatment of biochemical recurrence after radical prostatectomy (SHARE): the protocol of a prospective, randomized, open-label, superiority, multi-institutional trial.

Geumju Park, Yeon Joo Kim, Hanjong Ahn, Won Park, Ji Sung Lee, Young Seok Kim

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03920033 (Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 47% 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.

NCT03920033 narecruitingnot on this map

Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy (SHARE Trial): a Prospective, Randomized Controlled, Open-label, Multi Center, Superiority Study

TypeinterventionalSponsorAsan Medical CenterRan2019 to 2027Enrolled288ConditionsProstate Cancer, Biochemical Recurrence, Radiation, HypofractionationArmsSalvage radiation therapy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

6 authors at 3 institutions in 1 country.

Geumju ParkDepartment of Radiation Oncology, Inje University Haeundae Paik Hospital, Busan, Republic of Korea.
Yeon Joo KimDepartment of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.
Hanjong AhnDepartment of Urology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea.
Won ParkDepartment of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Ji Sung LeeClinical Research Center, Asan Institute for Life Science, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea.
Young Seok KimDepartment of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. ysk@amc.seoul.kr.ORCID http://orcid.org/0000-0003-4739-4476
Ulsan College · KRInje University Haeundae Paik Hospital · KRSamsung Medical Center · KR

Funding

Asan Institute for Life Sciences, Asan Medical Center 2019-0154
6 · The paper itself

Abstract

backgroundWhile several phase III trials have investigated the role of hypofractionated radiotherapy in the definitive treatment of localized prostate cancer, prospective data reporting the outcomes of hypofractionated radiotherapy in the postoperative treatment setting are sparse. Therefore, this study is designed to assess the efficacy and treatment-related toxicity of hypofractionated salvage radiotherapy for the treatment of biochemical recurrence in men who underwent radical prostatectomy. The primary objective of this trial is to investigate whether hypofractionated radiotherapy improves biochemical control compared with conventionally fractionated radiotherapy. In addition, treatment-related toxicity, quality of life, and survival will be evaluated as secondary endpoints.

methodsIn this prospective, randomized, multi-institutional trial (the SHARE study), patients with intermediate- or high-risk prostate cancer will be randomized to receive either hypofractionated radiotherapy (65 Gy in 2.5-Gy fractions) or conventionally fractionated radiotherapy (66 Gy in 2-Gy fractions). Prostate bed irradiation or elective pelvic nodal irradiation including the prostate bed will be performed using intensity-modulated radiotherapy and daily image guidance. Treatment efficacy will be assessed using the serum tumor marker prostate-specific antigen, and toxicity will be evaluated through both physician- and patient-reported outcomes. Quality of life will also be investigated. DISCUSSION: This study is designed to demonstrate whether hypofractionated radiotherapy is beneficial in terms of biochemical control and toxicity compared with standard salvage radiotherapy. If hypofractionated radiotherapy is shown to be superior to conventionally fractionated radiotherapy, it will mean that improved biochemical control can be achieved, accompanied by greater patient convenience and more efficient use of medical resources.

trial registrationClinicalTrials.gov NCT03920033. Registered on 18 April 2019.

Indexed as

ProstateQuality of LifeEquivalence Trials as TopicHumansMaleMulticenter Studies as TopicProspective StudiesProstatectomyRadiation Dose HypofractionationRandomized Controlled Trials as TopicHypofractionated radiotherapyProstate cancerSalvage radiotherapy

Identifiers

PMID34674739
PMCPMC8532339
OpenAlexW3206479551

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.