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Article History

Received: 22 October 2021

Accepted: 8 February 2022

First Online: 16 February 2022

Declarations

:

: This study was reviewed and approved by the Medical Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University on March 8th, 2021. Any amendments to the protocol will require review and approval by the committee before the changes are made. The study will be performed in accordance with the Declaration of Helsinki and the Good Clinical Practice (GCP) guidelines. All patients will understand and agree to the purposes of the trial, its methods, anticipated benefits and potential risks. The informed consent form for this study must be personally dated and signed by the patient and investigator, and a copy of the signed informed consent should be provided to the patient. All participating patients were ensured of personal identity information confidentiality and the rights to drop out of the study whenever required. The study protocol, documentation, data, and all other information generated will be held in strict confidence. No information concerning the research study or the data will be released to any unauthorized third party.

: Potential risks from the intervention: ADT combined with docetaxel 75 mg/m2 is the standard of usual care for patients with mCRPC, and adverse events are inherent to standard-of-care treatments, including neutropenia, fatigue, nausea, vomiting, diarrhoea, etc. Patients administered a modified regimen may suffer fewer adverse events at the cost of chemotherapy efficacy, which means that more effective treatments will be delayed and they may in consequence have a worse prognosis. A risk control plan was designed to prevent and cope with potential unexpected adverse events due to the study interventions. The study has to be stopped in case severe adverse events and disease progression occur due to the implementation of the intervention.

: Not applicable.

: The authors declare that they have no competing interests.