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Brief Title: Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
Official Title: A Randomized Phase IV Study Comparing Enzalutamide Versus Flutamide in Castration-resistant Prostate Cancer (CRPC) Patients Who Have Failed Combined Androgen Blockade Therapy With Bicalutamide Plus Androgen Deprivation Therapy (ADT)
Study ID: NCT02918968
Brief Summary: The objective of this study was to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with flutamide + ADT in patients with castration resistant prostate cancer who had relapsed during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study also investigated the order of alternative antiandrogen therapy (AAT) by changing the 1st line medication after relapse of prostate-specific antigen (PSA).
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Site JP00024, Nagoya, Aichi, Japan
Site JP00025, Nagoya, Aichi, Japan
Site JP00038, Matsuyama, Ehime, Japan
Site JP00051, Iizuka, Fukuoka, Japan
Site JP00045, Isesaki, Gunma, Japan
Site JP00005, Maebashi, Gunma, Japan
Site JP00043, Ota, Gunma, Japan
Site JP00054, Hakodate, Hokkaido, Japan
Site JP00001, Sapporo, Hokkaido, Japan
Site JP00002, Sapporo, Hokkaido, Japan
Site JP00048, Sapporo, Hokkaido, Japan
Site JP00055, Mito, Ibaraki, Japan
Site JP00019, Sagamihara, Kanagawa, Japan
Site JP00020, Yokohama, Kanagawa, Japan
Site JP00021, Yokohama, Kanagawa, Japan
Site JP00044, Yokosuka, Kanagawa, Japan
Site JP00046, Kashihara, Nara, Japan
Site JP00033, Kurashiki, Okayama, Japan
Site JP00028, Hirakata, Osaka, Japan
Site JP00030, Osakasayama, Osaka, Japan
Site JP00027, Suita, Osaka, Japan
Site JP00009, Kitaadachi-gun, Saitama, Japan
Site JP00022, Hamamatsu, Shizuoka, Japan
Site JP00049, Utsunomiya, Tochigi, Japan
Site JP00011, Bunkyo-ku, Tokyo, Japan
Site JP00017, Bunkyo-ku, Tokyo, Japan
Site JP00013, Koto-ku, Tokyo, Japan
Site JP00014, Nakano-ku, Tokyo, Japan
Site JP00016, Shinagawa-ku, Tokyo, Japan
Site JP00018, Shinjuku-ku, Tokyo, Japan
Site JP00034, Ube, Yamaguchi, Japan
Site JP00010, Chiba, , Japan
Site JP00053, Chiba, , Japan
Site JP00039, Fukuoka, , Japan
Site JP00040, Fukuoka, , Japan
Site JP00050, Fukuoka, , Japan
Site JP00035, Hiroshima, , Japan
Site JP00026, Kyoto, , Japan
Site JP00006, Nagano, , Japan
Site JP00008, Nagano, , Japan
Site JP00041, Nagasaki, , Japan
Site JP00029, Osaka, , Japan
Site JP00031, Osaka, , Japan
Site JP00032, Osaka, , Japan
Site JP00042, Saga, , Japan
Site JP00037, Tokushima, , Japan
Site JP00052, Toyama, , Japan
Name: Medical Director
Affiliation: Astellas Pharma Inc
Role: STUDY_DIRECTOR