Evidence map›Paper›PMID 33032643›Full record

Trial reportRadiation oncology (London, England)2020

Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR).

Yeon Joo Kim, Hanjong Ahn, Choung-Soo Kim, Young Seok Kim

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Radiation oncology (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03322020 (Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Men With Intermediate- or High-risk Prostate Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 26% 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.

NCT03322020 phase1 / phase2completednot on this map

Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Men With Intermediate- or High-risk Prostate Cancer

TypeinterventionalSponsorAsan Medical CenterRan2016 to 2019Enrolled30ConditionsNeoplasm, ProstateArmsCyberknife boost 18 Gy, Cyberknife boost 21 Gy
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. 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

4 authors at 1 institution in 1 country.

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.
Choung-Soo KimDepartment of Urology, 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 · KR

Funding

Asan Institute for Life Sciences, Asan Medical Center 2016-0314
6 · The paper itself

Abstract

backgroundTo evaluate the clinical outcomes of combination of androgen deprivation therapy (ADT), whole pelvic radiotherapy (WPRT), and stereotactic body radiotherapy (SBRT) boost in high-risk prostate cancer patients.

methodsThis prospective phase I/IIa study was conducted between 2016 and 2017. Following WPRT of 44 Gy in 20 fractions, patients were randomized to two boost doses, 18 Gy and 21 Gy, in 3 fractions using the Cyberknife system. Primary endpoints were incidences of acute toxicities and short-term biochemical recurrence-free survival (BCRFS). Secondary endpoints included late toxicities and short-term clinical progression-free survival (CPFS).

resultsA total of 26 patients were enrolled. Twelve patients received a boost dose of 18 Gy, and the rest received 21 Gy. The Median follow-up duration was 35 months. There were no grade ≥ 3 genitourinary (GU) or gastrointestinal (GI) toxicities. Sixty-one and 4% of patients experienced grade 1-2 acute GU and GI toxicities, respectively. There were 12% late grade 1-2 GU toxicities and 8% late grade 1-2 GI toxicities. Patient-reported outcomes of urinary symptoms were aggravated after WPRT and SBRT boost. However, they resolved at 1 month and returned to the baseline level at 4 months. Three-year BCRFS was 88.1%, and CPFS was 92.3%.

conclusionsThe present study protocol demonstrated that the combination of ADT, WPRT, and SBRT boosts for high-risk prostate cancer is safe and feasible, and may reduce total treatment time to 5 weeks. Boost dose of 21 Gy in 3 fractions seems appropriate.

trial registrationClinicalTrials.gov, ID; NCT03322020 - Retrospectively registered on 26 October 2017.

Indexed as

AgedAged, 80 and overAndrogen AntagonistsCombined Modality TherapyDose Fractionation, RadiationHumansMaleMiddle AgedProspective StudiesProstatic NeoplasmsRadiosurgeryRandom AllocationRe-IrradiationSurvival AnalysisTreatment OutcomeAndrogen AntagonistsProstate neoplasmsQuality of lifeRadiosurgeryRadiotherapyToxicity

Identifiers

PMID33032643
PMCPMC7542889
OpenAlexW3091952318

What OpenQuestion holds

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LicenceCC BY
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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.