Document is current

Article History

Received: 6 July 2023

Accepted: 21 March 2024

First Online: 8 April 2024

Declarations

:

: ClinicalTrials.gov Identifier: NCT06027892. Date of registration: 9/7/2023.Health.gov.il identifier: MOH_2022-08-30_012007. Date of registration: 8/30/2022.

: Deidentified participant data from this trial will not be shared publicly, however, the full protocol will be published along with the primary analysis of the outcomes.

: Ethics approval has been obtained from the Rabin Medical Center Helsinki Research Ethics Board (#199 − 22). All methods will be carried out in accordance with institutional and Ministry of Health of Israel guidelines and regulations. All aspects of the protocol were approved by Rabin Medical Center and it’s Ethics board. All individual study participants will provide written informed consent to participate in the study. A sample consent form is available upon request. Consent will be obtained by study investigators in conjunction with clinical trials staff.

: Not applicable.

: EF serves as a consultant to Boston Scientific for SpaceOAR and receives honoraria for clinical and educational work. Excluding the awarded competitive grant, no support, financial or otherwise, was received in connection with this work. All other authors declare no conflicts of interest and that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.