Clinical Trial Protocol

Protocol of the integrated boost to the dominant intraprostatic nodule in stereotactic body radiation therapy for localized prostate cancer

https://orcid.org/0000-0003-4096-3349

Department of Radiation Oncology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China

‡These authors contributed equally to this work

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Xiaofei Zhu^‡

Department of Radiation Oncology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China

‡These authors contributed equally to this work

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Chao Cheng^‡

Department of Nuclear Medicine, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China

‡These authors contributed equally to this work

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Lingong Jiang

Department of Radiation Oncology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China

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Yusheng Ye

Department of Radiation Oncology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China

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Yangsen Cao

Department of Radiation Oncology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China

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Yuchao Li

Department of Nuclear Medicine, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China

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Changjing Zuo

*Author for correspondence:

E-mail Address: changjing.zuo@qq.com

Department of Nuclear Medicine, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China

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Huojun Zhang

**Author for correspondence:

E-mail Address: huojunzh@163.com

Department of Radiation Oncology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China

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Published Online:12 Dec 2022https://doi.org/10.2217/fon-2022-0590

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Abstract

Aim: To explore the safety and efficacy of the integrated boost to the dominant intraprostatic nodule (DIN) based on ⁶⁸Ga prostate-specific membrane antigen PET/MRI in stereotactic body radiation therapy (SBRT) for patients with localized prostate cancer. Methods: SBRT regimen is employed – namely, sequential integrated boost (SIB) to the DIN based on ⁶⁸Ga prostate-specific membrane antigen PET/MRI. SIB prescription dose of 36.25 Gy in five fractions to fixed prophylactic tumoricidal region is delivered, followed by 7.25 Gy in one fraction added to the DIN every other day. The primary end point of the study will be toxicity assessed by the Common Terminology Criteria for Adverse Events 5.0 grading scale. Secondary end points include biochemical progression-free survival, local progression-free survival, distant metastasis-free survival and overall survival. Discussion: This trial is to prove the safety and efficacy of sequential integrated boost to the DIN in SBRT.

Clinical Trial Registration:NCT04599699 (ClinicalTrials.gov)

Keywords:

Papers of special note have been highlighted as: • of interest

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Vol. 18, No. 37

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History

Received 13 June 2022

Accepted 10 November 2022

Published online 12 December 2022

Published in print December 2022

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Keywords

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.futuremedicine.com/doi/suppl/10.2217/fon-2022-0590

Author contributions

Study conception: H Zhang, C Zuo; initial study design: X Zhao, X Zhu, C Cheng; revision of study design and protocol: H Zhang, C Zuo, X Zhao, X Zhu, Y Cao, C Cheng; study coordination: X Zhao, Y Li, L Jiang, Y Ye, Y Cao; drafting of the manuscript: X Zhao, X Zhu, C Cheng. All authors read and approved the final manuscript.

Acknowledgments

The authors warmly thank Dr J Chen from Accuray APAC and Dr Y Gao from CNNC Accuray (Tianjin) Medical Technology Co. Ltd for their help in the professionally stylistic ameliorations of the English language.

Financial & competing interests disclosure

This study is sponsored by National Key Research and Development Program of China (2017YFC0113104), the China Health Promotion Foundation (THC2015001), the First Affiliated Hospital of Naval Medical University ‘234 Subject Climbing Program’ (2019YPT004), the First Affiliated Hospital of Naval Medical University ‘Youth Startup Fund’ (2020QNB10), the Advanced and Appropriate Technology Popularization Project of Shanghai Municipal Health Commission (2019SY029) and the Shanghai Hospital Development Center Foundation (SHDC22020219). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

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