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Stereotactic body-radiotherapy boost dose of 18 Gy vs 21 Gy in combination with androgen-deprivation therapy and whole-pelvic radiotherapy for intermediate- or high-risk prostate cancer: a study…

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Title
Stereotactic body-radiotherapy boost dose of 18 Gy vs 21 Gy in combination with androgen-deprivation therapy and whole-pelvic radiotherapy for intermediate- or high-risk prostate cancer: a study protocol for a randomized controlled, pilot trial
Published in
Trials, April 2018
DOI 10.1186/s13063-018-2574-y
Pubmed ID
Authors

Yeon Joo Kim, Hanjong Ahn, Choung-Soo Kim, Jae-Lyun Lee, Young Seok Kim

Abstract

Combination therapy using external-beam radiotherapy (EBRT) with a brachytherapy boost has demonstrated superior biochemical control than dose-escalated EBRT alone. Whereas brachytherapy is disadvantageous because it is an invasive procedure, stereotactic body-radiotherapy (SBRT) using CyberKnife could emulate the dose distribution of brachytherapy and is a non-invasive and safe modality to control intra-fractional movement. We therefore adopted SBRT using CyberKnife as a boost therapy after whole-pelvic radiotherapy (WPRT). In this prospective, randomized, single-center, pilot study for intermediate- and high-risk prostate cancer without nodal or distant metastasis, after androgen-deprivation therapy and WPRT, patients will be randomized to one of two SBRT boost regimens, i.e., 18 or 21 Gy administered in three fractions every other day. The aim of this trial is to evaluate acute toxicities using both physician- and patient-reported outcomes and short-term biochemical control with SBRT boost following WPRT. Additionally, chronic toxicities and long-term biochemical control will be evaluated as secondary endpoints in this trial. Based on the generated results, we will plan the full-scale phase II study for selecting the SBRT boost dose. ClinicalTrials.gov, ID; NCT03322020 . Retrospectively registered on 26 October 2017.

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Geographical breakdown

Country Count As %
Unknown 38 100%

Demographic breakdown

Readers by professional status Count As %
Other 7 18%
Student > Bachelor 7 18%
Student > Postgraduate 4 11%
Student > Master 3 8%
Student > Doctoral Student 2 5%
Other 6 16%
Unknown 9 24%
Readers by discipline Count As %
Medicine and Dentistry 20 53%
Nursing and Health Professions 3 8%
Computer Science 1 3%
Biochemistry, Genetics and Molecular Biology 1 3%
Physics and Astronomy 1 3%
Other 1 3%
Unknown 11 29%