Funding

This study was funded by Sumitomo Pharma Switzerland GmbH in collaboration with Pfizer Inc.

Conflicts of interest

Jose De La Cerda has received honoraria from Johnson & Johnson, Pfizer, Dendreon, Foundation Medicine, and AstraZeneca; has been a consultant/advisor for Johnson & Johnson, Pfizer, Dendreon, Foundation Medicine, and AstraZeneca; has received research funding from Urology San Antonio; and has been part of the speakers' bureau for Johnson & Johnson and Foundation Medicine. Laurence Belkoff has been a consultant/advisor for Johnson & Johnson, Merck, Johnson & Johnson, Fellow Health, Exo Dx, Lantheus Medical Imaging, Blue Earth, Francis Medical, Boston Scientific, AstraZeneca, Propella Therapeutics, Dendreon, CG Oncology, and Immunity Bio, Ferring, and Prodeon Medical. Kevin D. Courtney has been a consultant/advisor for Novartis and has received research funding from Sumitomo Pharma/Myovant Sciences, Astellas Pharma, Lilly, Stemline Therapeutics, Clovis Oncology, Exelixis, Amgen, Harpoon Therapeutics, Pfizer, Surface Oncology, Novartis, Celgene/Bristol-Myers Squibb, AstraZeneca, Janssen Research and Development, and DualityBio. Elan Diamond received honoraria from Bayer and has been a consultant/advisor for AstraZeneca, Merck, and Bristol-Myers Squibb/Sanofi. Curtis Dunshee has been a consultant/advisor for Astellas, Bayer, Janssen, and Pfizer and has received research funding from Astellas, AstraZeneca, Bayer, Dendreon, Essa Pharmaceuticals, Pfizer, and Sumitomo Pharma. Michael Goodman received honoraria from Curio Science and Targeted Oncology and has been a consultant/advisor for Sanofi/Aventis and Alexion Pharmaceuticals. He has received research funding from Janssen, AstraZeneca, Genentech, and Bristol-Myers Squibb/Pfizer; and has received travel, accommodations, and expenses from AstraZeneca, Genentech, and Curio Science. Kriti Mittal has received honoraria from IntrinsiQ, Targeted Oncology, Medpage, Aptitude Health, and Cardinal Health. She has been a consultant/advisor for Bayer, Aveo, Dendreon, Myovant Sciences, Curio Science, and Janssen AstraZeneca and has received research funding from Pfizer. David Morris has been a consultant/advisor for Janssen Oncology, Clovis Oncology, Astellas Pharma, Bayer, Urogen Pharma, Myriad Genetics, UROGPO, Pfizer/EMD Serono, Decipher Biosciences, AstraZeneca, Myovant Sciences, Merck Serono, Dendreon, Blue Earth Diagnostics, and Lantheus Medical Imaging. He has received research funding from Merck, Janssen Oncology, Astellas Pharma, Urogen Pharma, Pfizer/Astellas, Dendreon, Exelixis, Bayer, Clovis Oncology, and AstraZeneca/Merck; and has also been part of the speakers' bureau for AstraZeneca, Janssen, Clovis Oncology, Astellas Medivation, and Merck. Paul Sieber received honoraria from Bayer, Pfizer, and Foundation Medicine and has received research funding from Astellas Pharma, Pfizer, AstraZeneca, Merck, ORIC Pharmaceuticals, CG Therapeutics, Janssen, Dendreon, and Bayer. He has been part of the speakers' bureau for Astellas Pharma, Bayer, Dendreon, Merck, Pfizer, Janssen, Bayer Germany, Pfizer/NCCN, Dendreon, Astellas, and Merck. Ronald Tutrone has been a consultant/advisor for Astellas and has received research funding from Astellas, Arvinas, AstraZeneca, Bayer, Dendreon, Essa Pharmaceuticals, Merck, OncC4, Pfizer, Janssen, and Sumitomo Pharma. Michael Ryan is an employee of Pfizer, Inc. Yi Zhong is an employee of Sumitomo Pharma America, Inc. Mike Ufer is an employee of Sumitomo Pharma Switzerland GmbH. Neal Shore has been a consultant/advisor for Bayer, Janssen Scientific Affairs, Dendreon, Tolmar, Ferring, Medivation/Astellas, Amgen, Pfizer, AstraZeneca, Astellas Pharma, Merck, Bristol-Myers Squibb/Sanofi, Exact Imaging, InVitae, MDxHealth, Myriad Genetics, Propella Therapeutics, Sanofi, Urogen Pharma, Specialty Networks, Peerview, Clarity Pharmaceuticals, Lantheus Medical Imaging, Lilly, Photocure, Telix Pharmaceuticals, Arquer Diagnostics, Asieris Pharmaceuticals, Minomic, Novartis, PlatformQ Health, Promaxo, Protara Therapeutics, Fize Medical, Accord Research, Antev, Aura Biosciences, Bioprotect, Sumitomo Pharma, Siemens, Alessa Therapeutics, CG Oncology, Glytherix, and Tutelix. He has received research funding from Abbvie, Amgen, Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb/Pfizer, Boston Scientific, Clovis Oncology, Dendreon, Exact Imaging, Ferring, Foundation Medicine, InVitae, Janssen, MDxHealth, Merck, Myovant Sciences, Myriad Genetics, Nymox, Pfizer, Sanofi, Sesen Bio, Tolmar, CG Oncology, DisperSol, FORMA Therapeutics, Guardant Health, Jiangsu Yahong Meditech, Novartis, Pacific Edge, POINT Biopharma, Propella Therapeutics, SeaGen, MT Group, Theralase, Veru, Zenflow, Advantagene, Aragon Pharmaceuticals, Endocyte, Exelixis, FKD Therapies, Genentech, ISTARI Oncology, Medivation, OncoCellMDx, ORIC Pharmaceuticals, Palette Life Sciences, Plexxikon, RhoVac, Steba Biotech, Urogen Pharma, Urotronic, US Biotest, and Vaxiion. He has also been employed by GenesisCare. Neal Shore is an Editorial Board member of Targeted Oncology. Neal Shore was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.

Ethics approval

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.

Consent to participate

All patients provided written informed consent before screening.

Consent to publish

Not applicable.

Availability of data and material

Sumitomo Pharma Switzerland, GmbH 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 may be available through ClinicalTrials.gov.

Code availability

Not applicable.

Author contributions

All authors contributed to the design and/or conduct of this study and met the authorship criteria based on the International Committee of Medical Journal Editors. The manuscript was reviewed and approved by all authors. JC, LB, KDC, ED, JO, CD, LG, MG, KM, DM, PS, RT, NS were clinical investigators who also provided medical and scientific expertise regarding study design and data interpretation. YZ was the study statistician. MR and MU served as medical leads from Pfizer and Sumitomo Pharma, respectively.