De La Cerda, Jose
Dunshee, Curtis
Gervasi, Lawrence
Sieber, Paul
Belkoff, Laurence
Tutrone, Ronald
Lu, Sophia
Gatoulis, Sergio C.
Brown, Bruce
Migoya, Elizabeth
Shore, Neal
Article History
Accepted: 28 March 2023
First Online: 15 April 2023
Declarations
:
: Myovant Sciences GmbH in collaboration with Pfizer Inc.
: Elizabeth Migoya, Bruce Brown, and Sophia Lu are employees of Myovant. Sergio C. Gatoulis is an employee of Pfizer. Laurence Belkoff: Consultant for Marius Pharm and Astellas. Lawrence Gervasi: Speakers bureau for Astellas, Bayer, Dendreon, Janssen, and Myovant. Jose De La Cerda: Consulting or advisory role with Dendreon, Myriad Pharmaceuticals, and Pfizer/Astellas. Curtis Dunshee: Consulting/advisory role and research funding from Astellas and Pfizer; consulting/advisory role for Pfizer during the conduct of this study; and research funding from Janssen Oncology, Dendreon, Myovant Sciences, and AstraZeneca. Paul Sieber: Advisory role for Pfizer and Verity; research funding from Astellas, AstraZeneca, Bayer, Dendreon, Janssen, Merck, Myovant, Orion, and Pfizer; and speaker’s bureau for Astellas, Bayer, Dendreon, Janssen, Merck, Myovant, and Pfizer. Neal Shore: Consulting or advisory role for Bayer, Janssen Scientific Affairs, Dendreon, Tolmar, Ferring, Medivation/Astellas, Amgen, Pfizer, AstraZeneca, Genentech, and Myovant Sciences; speakers’ bureau for Janssen, Bayer, and Dendreon. Ronald Tutrone: Speakers bureau for Myovant Sciences, Astellas, Pfizer, and Exosome; consultant/advisory board for Propella Pharm, Myovant Sciences, and Bayer.
: Myovant is the owner of the raw data, which it considers to be proprietary and does not share the data with anyone other than regulatory authorities. At the conclusion of the study, results will be available through ClinicalTrials.gov and other public outlets.
: Independent Institutional Review Boards at all participating institutions approved the study, which was conducted in accordance with International Council for Harmonisation guidelines for Good Clinical Practice and according to the principles of the Declaration of Helsinki.
: All patients provided written informed consent.
: Informed consent was obtained from all individual participants included in the study. No patient-identifying information is included in this article, therefore consent to publish was not required.
: Not applicable.
: All authors participated in the design and conduct of this study, had access to the data, drafted the manuscript with input from the sponsor (Myovant), reviewed and approved the manuscript before submission, made the decision to submit the manuscript for publication, and agreed to be accountable for all aspects of this work. Sophia Lu had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.