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

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

Abstract

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.

Keywords: External-beam radiotherapy; Prostate cancer; Stereotactic radiotherapy boost.

Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Flowchart of treatments for the trial. *Risk group defined as per National Comprehensive Center Network (NCCN) guidelines
Fig. 2
Fig. 2
Intervention and assessment schedule for the trial according to the Recommendations for Interventional Trials (SPIRIT)

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