Coadministration of Apalutamide and Relugolix in Patients with Localized Prostate Cancer at High Risk for Metastases

Funding

This study was funded by Janssen US Medical Affairs. The sponsor was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation and review of the manuscript. The sponsor paid the open access fee.

Conflict of interest

Gordon Brown: Consultant/advisor, speakers’ bureau, expert testimony: Astellas Pharma, Bayer, Janssen, Merck, and Pfizer; research funding: Janssen Biotech, Merck. Jason M. Hafron: Consultant/advisor: Astellas Pharma Inc., Dendreon Pharmaceuticals LLC, Janssen Biotech Inc., Myriad Genetic Laboratories, Myovant Sciences, Pfizer Inc., Promaxo, Lynx DX; meeting participant/lecturer: Astellas Pharma Inc., Amgen Inc., Bayer, Blue Earth Diagnostics, Dendreon Pharmaceuticals LLC, Janssen Biotech Inc., Lantheus, Merck & Co., Myriad Genetic Laboratories, Myovant Sciences, Pfizer Inc., Procept-Biorobotic, Progenics Pharmaceuticals, Inc., Tolmar Pharmaceuticals Inc., Urogen Pharma Inc. Neal D. Shore: Consultant/advisor: AbbVie, Amgen, Astellas Pharma, AstraZeneca, Bayer, Boston Scientific, Bristol-Myers Squibb/Sanofi, Clarity Pharmaceuticals, CG Oncology, Clovis Oncology, Dendreon, Exact Imaging, Exact Sciences, FerGene, Ferring, Foundation Medicine, Genesis Cancer Care, Genzyme, InVitae, Janssen Scientific Affairs, Lantheus, Lilly, MDxHealth, Medivation/Astellas, Merck, Myovant Sciences, Myriad Genetics, Nymox, Pacific Edge Biotechnology, Pfizer, Phosphorus, Sanofi, Sema4, Sesen Bio, Specialty Networks, Peerview, Photocure, Propella Therapeutics, Telix Pharmaceuticals, Tempus, Tolmar, Urogen Pharma, Vaxiion; speakers’ bureau: Astellas Pharma, AstraZeneca, Bayer, Janssen, Clovis Oncology, Foundation Medicine, Guardant Health, Merck, Pfizer; expert testimony: Ferring; research finding: AbbVie, Advantagene, Amgen, Aragon Pharmaceuticals, Astellas Pharma, AstraZeneca, Bayer, Boston Scientific, Bristol-Myers Squibb/Pfizer, CG Oncology, Clovis Oncology, Dendreon, DisperSol, Endocyte, Exact Imaging, Exelixis, Ferring, FKD Therapies, FORMA Therapeutics, Foundation Medicine, Genentech, Guardant Health, InVitae, ISTARI Oncology, Janssen, Jiangsu Yahong Meditech, MDxHealth, Medivation, Merck, MT Group, Myovant Sciences, Myriad Genetics, Novartis, Nymox, OncoCellMDx, Pacific Edge, Palette Life Sciences, Pfizer, Plexxikon, POINT Biopharma, Propella Therapeutics, RhoVac, Sanofi, Seattle Genetics, Sesen Bio, Steba Biotech, Theralase, Tolmar, Very, Urogen Pharma, Urotronic, US Biotest, Vaxiion, Zenflow. Rushikesh Potdar, Amitabha Bhaumik, Jennifer Phillips, and Tracy McGowan are employees of Janssen US Medical Affairs or Janssen Research & Development and may hold stock in Johnson & Johnson. Laurence Belkoff and Daniel R. Saltzstein have no conflicts of interest to declare.

Availability of Data and Material

The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through the Yale Open Data Access (YODA) Project site at http://yoda.yale.edu.

Code Availability

Not applicable.

Ethics Approval

Independent Ethics Committees or Institutional Review Boards at all participating institutions approved the Apa-RP 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.

Consent to Participate

All patients provided written informed consent.

Consent to Publish

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.

Author Contributions

All authors participated in the design and conduct of the study, had access to the data, drafted the manuscript with input from the sponsor (Janssen), 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. Gordon Brown 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.

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