Azad, Arun A.
Armstrong, Andrew J. http://orcid.org/0000-0001-7012-1754
Alcaraz, Antonio
Szmulewitz, Russell Z.
Petrylak, Daniel P.
Holzbeierlein, Jeffrey
Villers, Arnauld
Alekseev, Boris
Iguchi, Taro
Shore, Neal D.
Gomez-Veiga, Francisco
Rosbrook, Brad
Lee, Ho-Jin
Haas, Gabriel P.
Stenzl, Arnulf
Article History
Received: 29 March 2021
Revised: 28 July 2021
Accepted: 3 August 2021
First Online: 21 August 2021
Competing interests
: AAA has served in a consultant/advisory role for Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Janssen, Merck Serono, MSD, Novartis, Noxopharm, Pfizer, Sanofi, Telix Pharmaceuticals, and Tolmar and on speakers’ bureaus for Astellas, Amgen, Bayer, Ipsen, Janssen, Merck Serono, Novartis, Pfizer, and Sanofi and has received investigator or institutional funding from Aptevo Therapeutics, Astellas, AstraZeneca, Bionomics, Bristol Myers Squibb, GlaxoSmithKline, Ipsen, Novartis, MedImmune, Merck Serono, Pfizer, Sanofi Aventis, and SYNthorx and travel accommodation/expenses from Amgen, Astellas, Janssen, Merck Serono, Novartis, Pfizer, and Tolmar. AJA has served in a consultant/advisory role for Astellas, AstraZeneca, Bayer, Clovis, Dendreon, Janssen, Medivation, Merck, Novartis, Pfizer, and Sanofi and on speakers’ bureau for Bayer and Dendreon and has received research funding from Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Constellation, Dendreon, Janssen, Medivation, Merck, Novartis, Pfizer, Roche/Genentech, and Sanofi, honoraria from Dendreon, Janssen, and Sanofi, and travel accommodation/expenses from Astellas, Bayer, Dendreon, and Janssen. AA has received travel/accommodation/expenses from Astellas, Bayer, Ipsen, Janssen, and Olympus. RZS has served in a consultant/advisory role for AstraZeneca, AbbVie, Amgen, Astellas, Exelixis, Janssen Oncology, Merck, Sanofi, and Pfizer, has received research funding from Astellas, AbbVie, Incyte, Janssen Oncology, and Macrogenics, honoraria from Astellas, and travel accommodation/expenses from Corcept Therapeutics, and is the coinventor to Corcept Therapeutics patent licensed by The University of Chicago for combination AR/GR inhibition in prostate cancer. DPP has served in a consultant/advisory role for Ada Cap (Advanced Accelerator Applications), Amgen, Astellas, AstraZeneca, Bayer, Bicycle Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Clovis Oncology, Exelixis, Incyte, Janssen, Lilly, Mirati, Monopteros, Pfizer, Pharmacyclics, Roche, Seattle Genetics, and Urogen, has received research funding from Ada Cap (Advanced Accelerator Applications), Agensys Inc, Astellas, AstraZeneca, Bayer, BioXcel Therapeutics, Bristol Myers Squibb, Clovis Oncology, Eisai, Endocyte, Genentech, Innocrin, Lilly, MedImmune, Medivation, Merck, Mirati, Novartis, Pfizer, Progenics, Replimune, Roche, Sanofi Aventis, and Seattle Genetics, and had stock ownership in Bellicum Pharmaceuticals (sold July 2020) and Tyme (sold October 2019). JH has received research funding from Astellas and has been an investigator for MDxHealth. AV has received research funding from Astellas and Ipsen and personal fees from Astellas. BA has served in a consultant/advisory role for Astellas, AstraZeneca, Bayer, BMS, Eisai, Ferring, Janssen, MSD, Pfizer, Roche, and Sanofi and on speakers’ bureau for Astellas, AstraZeneca, Bayer, BMS, Eisai, Ferring, Janssen, MSD, Pfizer, Roche, and Sanofi and has received research funding from Astellas, AstraZeneca, Bayer, BMS, Eisai, Ferring, Janssen, MSD, Pfizer, Roche, and Sanofi and travel accommodation/expenses from Astellas, AstraZeneca, Bayer, BMS, Eisai, Ferring, Janssen, MSD, Pfizer, Roche, and Sanofi. TI has served in a consultant/advisory role for Astellas, Bayer, and Janssen and on speakers’ bureau for Astellas, Bayer, Janssen, and Sanofi and has received research funding from Astellas and Bayer. NDS has served in a consultant/advisory role for Amgen, Astellas, AstraZeneca, Bayer, Dendreon, Ferring, Genentech/Roche, Janssen Scientific Affairs, Medivation, Myovant Sciences, Pfizer, and Tolmar and on speakers’ bureau for Bayer, Dendreon, and Janssen and has received research funding from Amgen, Astellas, AstraZeneca, Bayer, Dendreon, Ferring, Genentech/Roche, Janssen Scientific Affairs, Medivation, Myovant Sciences, Pfizer, and Tolmar and travel accommodation/expenses from Amgen, Astellas, AstraZeneca, Bayer, Dendreon, Ferring, Genentech/Roche, Janssen Scientific Affairs, Medivation, Myovant Sciences, Pfizer, and Tolmar. FG-V has served in a consultant/advisory role for AbbVie, Astellas, AstraZeneca, Bayer, Ferring, GE Healthcare, GlaxoSmithKline, Ipsen, Janssen, and Sanofi and has received honoraria from AbbVie, Astellas, AstraZeneca, Bayer, Ferring, GE Healthcare, GlaxoSmithKline, Ipsen, Janssen, and Sanofi and research funding from AbbVie, Astellas, and AstraZeneca. BR is an employee and has stock ownership in Pfizer. H-JL and GPH are employees of Astellas. AS has served in a consultant/advisory role for Alere, Astellas, Bristol Myers Squibb, Ferring, Ipsen Pharma, Janssen, Roche, Stebatiotechnology, and Synergo, as an investigator for Amgen, Astellas, AstraZeneca, Cepheid, CureVac, GeneDX Bioscience, Immatics, Janssen, Johnson & Johnson, Karl Storz AG, Medivation, Novartis, and Roche, and on speakers’ bureau for Astellas, CureVac, Ipsen Pharma, Janssen, and Sanofi Aventis, has received travel accommodation/expenses from CureVac, Ferring, Ipsen Pharma, Janssen, and Sanofi Aventis, has provided expert testimony for GBA, and has patents pending—A290/99, AT00/0001:C-Trap, and 2018/6579.
: The study protocol was approved by local independent review boards and conducted according to provisions of the Declaration of Helsinki and Good Clinical Practice Guidelines of the International Conference on Harmonisation. All patients provided written informed consent. An independent data safety monitoring board evaluated unblinded safety data on an ongoing basis.