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

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

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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 Fire Table 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 Tree 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.