Calais, Jeremie https://orcid.org/0000-0002-8839-4379
Czernin, Johannes
Fendler, Wolfgang P.
Elashoff, David
Nickols, Nicholas G.
Funding for this research was provided by:
Philippe Foundation Inc.
Deutsche Forschungsgemeinschaft (807122)
Prostate Cancer Foundation (Young Investigator)
Stop Cancer (Career Development Award)
Prostate Cancer Foundation (17CHAL02)
National Cancer Institute (P30CA016042)
US department of energy (DESC0012353)
Fondation ARC pour la Recherche sur le Cancer (SAE20160604150)
VA CDA2 (5IK2BX002520)
Article History
Received: 17 August 2018
Accepted: 9 December 2018
First Online: 7 January 2019
Change Date: 21 January 2019
Change Type: Correction
Change Details: Following publication of the original article [1], we have been notified that one of the author names was listed incorrectly.
Ethics approval and consent to participate
: The protocol, the ICF and all forms of participant information related to the study have been reviewed and approved by the UCLA institutional review board (UCLA IRB#18–000484). Any changes made to the protocol will be submitted as a modification and will be approved by the IRB prior to implementation. All subjects must sign and personally date the IRB approved ICF after receiving detailed written and verbal information about the reason, the nature and the details of the trial prior to the initiation of any study-related procedures. This will be done according to the guidelines provided in the Declaration of Helsinki, ICH E6 Guideline for Good Clinical Practice (GCP) and government regulations, including (as applicable) the US Code of Federal Regulations Title 21 CFR 50.20 through 50.27. The subject must be made aware and agree that personal information may be reviewed during an audit by competent authorities and properly authorized persons. However, personal information will be treated as strictly confidential and will not be publicly available. The UCLA Nuclear Medicine research team will enter all data of each patient into REDCap database. Only the UCLA Nuclear Medicine research team will have access to the REDCap database (protected and encrypted access). Patients will be informed of the extent to which their confidential health information generated from this study may be used for research and publication purposes. Following this discussion, they will be asked to sign the HIPAA form and informed consent documents. The original signed document will become part of the patient’s medical records, and each patient will receive a copy of the signed document. The use and disclosure of protected health information will be limited to the individuals described in the informed consent document. ICF and HIPAA form will be given to the patient for review. Consent will be obtained after a clear and thorough discussion between the patient and the consenting physician. If the patient is from outside UCLA, he will have a phone consultation with the UCLA research team in coordination with the treating radiation oncologist to explain and discuss all the above points. Signed ICF and HIPAA form will be obtained by fax or email in this case.
: Johannes Czernin is a founder, board member, and holds equity in Sofie biosciences and Trethera Therapeutics. Intellectual property is patented by the University of California and licensed to Sofie Biosciences and Trethera Therapeutics.No other potential conflict of interest relevant to this article was reported.
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