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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 protocol for a randomized controlled, pilot trial.

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.

SUBMITTER: Kim YJ

PROVIDER: S-EPMC5879839 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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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 protocol for a randomized controlled, pilot trial.

Kim Yeon Joo YJ Ahn Hanjong H Kim Choung-Soo CS Lee Jae-Lyun JL Kim Young Seok YS

Trials 20180402 1

<h4>Background</h4>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 boos ...[more]

PMID: 29609646

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Project description:IntroductionThe systemic therapy, especially androgen deprivation therapy (ADT), is currently recommended for patients with oligometastatic prostate cancer (PCa). However, the results have not been satisfactory including adverse reactions and castration resistance. Therefore, it is necessary to explore more effective treatment to prolong biochemical progression-free survival (bPFS) and delay the start of hormonal therapy for treating oligometastatic PCa. Stereotactic body radiotherapy (SBRT) is an emerging treatment alternative for patients with oligometastases with high local control rates and minimal toxic effects. This prospective trial aims to demonstrate whether SBRT for the oligometastases of hormone-sensitive PCa can delay the start of ADT and prolong the time from inception of the study to castration-resistant prostate cancer (CRPC).Methods and analysisPatients with ≤3 oligometastatic recurrences, diagnosed on Ga-68 prostate-specific membrane antigen PET/CT, will be randomised in a 1:1 ratio between arm A (ADT only) and arm B (SBRT for oligometastases only). SBRT is conducted by CyberKnife with prescription dose 30-50 Gy in 3-5 fractions. One of the primary endpoints is ADT-free survival of arm B, the other is the time from inception of the study to CRPC. The secondary endpoints include radiotherapy-related toxicity, ADT-related toxicity, bPFS, local PFS and overall survival. Toxicity will be assessed using the National Cancer Institute Common Toxicity Criteria V.5.0.Ethics and disseminationThis protocol was approved by the institutional review board of Shanghai Changhai Hospital (CHEC2020-101). This is a randomised control clinical trial comparing SBRT to ADT for men with oligometastatic PCa. The study will be performed in compliance with applicable local legislation and in accordance with the ethical principles developed by the World Medical Association in the Declaration of Helsinki 2013. Study results will be disseminated through conferences and peer-reviewed scientific journals.Trial registration numberClinicaltrials.gov identifier:NCT04599686.

Dataset Information

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.

Publications

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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