PMID- 29609646
OWN - NLM
STAT- MEDLINE
DCOM- 20190618
LR  - 20190618
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 19
IP  - 1
DP  - 2018 Apr 2
TI  - 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.
PG  - 212
LID - 10.1186/s13063-018-2574-y [doi]
LID - 212
AB  - BACKGROUND: 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). 
      METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: 
      ClinicalTrials.gov, ID; NCT03322020 . Retrospectively registered on 26 October 
      2017.
FAU - Kim, Yeon Joo
AU  - Kim YJ
AD  - Department of Radiation Oncology, Asan Medical Center, University of Ulsan, 
      College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of 
      Korea.
FAU - Ahn, Hanjong
AU  - Ahn H
AD  - Department of Urology, Asan Medical Center, University of Ulsan, College of 
      Medicine, Seoul, Republic of Korea.
FAU - Kim, Choung-Soo
AU  - Kim CS
AD  - Department of Urology, Asan Medical Center, University of Ulsan, College of 
      Medicine, Seoul, Republic of Korea.
FAU - Lee, Jae-Lyun
AU  - Lee JL
AD  - Department of Oncology, Asan Medical Center, University of Ulsan, College of 
      Medicine, Seoul, Republic of Korea.
FAU - Kim, Young Seok
AU  - Kim YS
AD  - Department 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.
LA  - eng
SI  - ClinicalTrials.gov/NCT03322020
GR  - 2016-0314/Asan Institute for Life Sciences, Asan Medical Center/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20180402
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Androgen Antagonists)
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Androgen Antagonists/adverse effects/*therapeutic use
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Chemoradiotherapy/adverse effects/*methods
MH  - *Dose Fractionation, Radiation
MH  - Humans
MH  - Male
MH  - Patient Reported Outcome Measures
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Prostatic Neoplasms/pathology/*therapy
MH  - *Radiosurgery/adverse effects
MH  - Randomized Controlled Trials as Topic
MH  - Risk Factors
MH  - Seoul
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC5879839
OTO - NOTNLM
OT  - External-beam radiotherapy
OT  - Prostate cancer
OT  - Stereotactic radiotherapy boost
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: Approval to conduct this study 
      (version 1.1 on 21 March 2016) was granted by the Institutional Review Board of 
      Seoul Asan Medical Center (S2016-0351), and patient consent will be obtained 
      before randomization. CONSENT FOR PUBLICATION: Not applicable COMPETING 
      INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S 
      NOTE: Springer Nature remains neutral with regard to jurisdictional claims in 
      published maps and institutional affiliations.
EDAT- 2018/04/04 06:00
MHDA- 2019/06/19 06:00
PMCR- 2018/04/02
CRDT- 2018/04/04 06:00
PHST- 2018/01/02 00:00 [received]
PHST- 2018/03/01 00:00 [accepted]
PHST- 2018/04/04 06:00 [entrez]
PHST- 2018/04/04 06:00 [pubmed]
PHST- 2019/06/19 06:00 [medline]
PHST- 2018/04/02 00:00 [pmc-release]
AID - 10.1186/s13063-018-2574-y [pii]
AID - 2574 [pii]
AID - 10.1186/s13063-018-2574-y [doi]
PST - epublish
SO  - Trials. 2018 Apr 2;19(1):212. doi: 10.1186/s13063-018-2574-y.