Study 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).

Additional Study Details

Phase
Phase 4
Product
enzalutamide
Product
Enzalutamide
Flutamide
Type
Interventional
Masking
None (Open Label)
Enrollment number
206
Show Additional Study Details

Study documents

Scientific Results Summary
Available Language(s): English
Plain Language Summary
Available Language(s): Japanese
Protocol
Available Language(s): English
Statistical Analysis Plan (SAP)
Available Language(s): English

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  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
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  • Israel
  • Italy
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  • Thailand
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  • Ukraine
  • United Kingdom
  • United States
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    Locations

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    Completed
    Site JP00032
    Osaka, Osaka, Japan
    Completed
    Site JP00022
    Hamamatsu, Shizuoka, Japan
    Completed
    Site JP00048
    Sapporo, Hokkaido, Japan
    Completed
    Site JP00031
    Osaka, Osaka, Japan
    Completed
    Site JP00044
    Yokosuka, Kanagawa, Japan
    Completed
    Site JP00030
    Osakasayama, Osaka, Japan
    Completed
    Site JP00050
    Fukuoka, Fukuoka, Japan
    Completed
    Site JP00001
    Sapporo, Hokkaido, Japan
    Completed
    Site JP00028
    Hirakata, Osaka, Japan
    Completed
    Site JP00038
    Matsuyama, Ehime, Japan
    Completed
    Site JP00040
    Fukuoka, Fukuoka, Japan
    Completed
    Site JP00025
    Nagoya, Aichi, Japan
    Completed
    Site JP00043
    Ota, Gunma, Japan
    Completed
    Site JP00017
    Bunkyo-ku, Tokyo, Japan
    Completed
    Site JP00020
    Yokohama, Kanagawa, Japan
    Completed
    Site JP00035
    Hiroshima, Hiroshima, Japan
    Completed
    Site JP00019
    Sagamihara, Kanagawa, Japan
    Completed
    Site JP00052
    Toyama, Toyama, Japan
    Completed
    Site JP00055
    Mito, Ibaraki, Japan
    Completed
    Site JP00002
    Sapporo, Hokkaido, Japan
    Completed
    Site JP00021
    Yokohama, Kanagawa, Japan
    Completed
    Site JP00010
    Chiba, Chiba, Japan
    Completed
    Site JP00039
    Fukuoka, Fukuoka, Japan
    Completed
    Site JP00034
    Ube, Yamaguchi, Japan
    Completed
    Site JP00049
    Utsunomiya, Tochigi, Japan
    Completed
    Site JP00016
    Shinagawa-ku, Tokyo, Japan
    Completed
    Site JP00011
    Bunkyo-ku, Tokyo, Japan
    Completed
    Site JP00013
    Koto-ku, Tokyo, Japan
    Completed
    Site JP00046
    Kashihara, Nara, Japan
    Completed
    Site JP00054
    Hakodate, Hokkaido, Japan
    Completed
    Site JP00027
    Suita, Osaka, Japan
    Completed
    Site JP00024
    Nagoya, Aichi, Japan
    Completed
    Site JP00053
    Chiba, Chiba, Japan
    Completed
    Site JP00006
    Nagano, Nagano, Japan
    Completed
    Site JP00026
    Kyoto, Kyoto, Japan
    Completed
    Site JP00014
    Nakano-ku, Tokyo, Japan
    Completed
    Site JP00005
    Maebashi, Gunma, Japan
    Completed
    Site JP00033
    Kurashiki, Okayama, Japan
    Completed
    Site JP00018
    Shinjuku-ku, Tokyo, Japan
    Completed
    Site JP00045
    Isesaki, Gunma, Japan
    Completed
    Site JP00029
    Osaka, Osaka, Japan
    Completed
    Site JP00008
    Nagano, Nagano, Japan
    Completed
    Site JP00009
    Kitaadachi-gun, Saitama, Japan
    Completed
    Site JP00051
    Iizuka, Fukuoka, Japan
    Completed
    Site JP00041
    Nagasaki, Nagasaki, Japan
    Completed
    Site JP00037
    Tokushima, Tokushima, Japan
    Completed
    Site JP00042
    Saga, Saga, Japan

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