Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg (CAMON)
21. januar 2013 opdateret af: AstraZeneca
To gather information on the safety of monotherapy of Casodex® tablets 80 mg, targeting prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration).
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
712
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Aichi, Japan
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Akita, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Hiroshima, Japan
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Kochi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Nagasaki, Japan
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Nara, Japan
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Okayama, Japan
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Osaka, Japan
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Saitama, Japan
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Shizuoka, Japan
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Tokushima, Japan
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Tottori, Japan
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Toyama, Japan
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Wakayama, Japan
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Yamagata, Japan
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Aichi
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Houmei, Aichi, Japan
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Inuyama, Aichi, Japan
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Kasugai, Aichi, Japan
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Nagoya, Aichi, Japan
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Okazaki, Aichi, Japan
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Toyohashi, Aichi, Japan
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Toyota, Aichi, Japan
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Akita
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Odate, Akita, Japan
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Aomori
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Hirosaki, Aomori, Japan
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Chiba
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Asahi, Chiba, Japan
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Funahashi, Chiba, Japan
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Ichihara, Chiba, Japan
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Ichikawa, Chiba, Japan
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Narashino, Chiba, Japan
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Sakura, Chiba, Japan
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Ehime
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Imabari, Ehime, Japan
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Matsuyama, Ehime, Japan
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Niihama, Ehime, Japan
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Uwajima, Ehime, Japan
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Fukuoka
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Chikushino, Fukuoka, Japan
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Iizuka, Fukuoka, Japan
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Kasuga, Fukuoka, Japan
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Kita Kyushu, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Yukuhashi, Fukuoka, Japan
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Fukushima
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Aizuwakamatsu, Fukushima, Japan
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Gifu
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Ibi, Gifu, Japan
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Kani, Gifu, Japan
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Minokamo, Gifu, Japan
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Mizunami, Gifu, Japan
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Ogaki, Gifu, Japan
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Seki, Gifu, Japan
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Yamagata, Gifu, Japan
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Yourou, Gifu, Japan
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Gunma
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Isesaki, Gunma, Japan
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Kiryu, Gunma, Japan
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Numata, Gunma, Japan
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Ohta, Gunma, Japan
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Takasaki, Gunma, Japan
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Hokkaido
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Asahikawa, Hokkaido, Japan
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Eniwa, Hokkaido, Japan
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Kushiro, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Sunagawa, Hokkaido, Japan
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Tomakomai, Hokkaido, Japan
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Hyogo
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Akashi, Hyogo, Japan
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Katou, Hyogo, Japan
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Kobe, Hyogo, Japan
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Takarazuka, Hyogo, Japan
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Ibaraki
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Hitachi, Ibaraki, Japan
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Mito, Ibaraki, Japan
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Sashima, Ibaraki, Japan
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Toride, Ibaraki, Japan
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Tsuchiura, Ibaraki, Japan
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Ishihawa
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Hakusan, Ishihawa, Japan
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Iwate
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Ichinoseki, Iwate, Japan
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Kamaishi, Iwate, Japan
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Miyako, Iwate, Japan
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Morioka, Iwate, Japan
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Shiwa, Iwate, Japan
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Kagawa
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Takamatsu, Kagawa, Japan
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Zentrsuji, Kagawa, Japan
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Kagoshima
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Minami Satsuma, Kagoshima, Japan
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Kanagawa
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Atsugi, Kanagawa, Japan
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Chigasaki, Kanagawa, Japan
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Ebina, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Yamato, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokosuka, Kanagawa, Japan
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Kyoto
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Nantan, Kyoto, Japan
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Mie
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Inabe, Mie, Japan
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Tsu, Mie, Japan
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Miyagi
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Matsushima, Miyagi, Japan
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Natori, Miyagi, Japan
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Sendai, Miyagi, Japan
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Shiogama, Miyagi, Japan
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Tagajo, Miyagi, Japan
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Nagasaki
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Isahaya, Nagasaki, Japan
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Sasebo, Nagasaki, Japan
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Nara
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Ikoma, Nara, Japan
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Kashiba, Nara, Japan
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Niigata
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Gosen, Niigata, Japan
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Tsubame, Niigata, Japan
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Oita
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Nakatsu, Oita, Japan
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Okayama
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Kurashiki, Okayama, Japan
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Osaka
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Habikino, Osaka, Japan
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Ibaraki, Osaka, Japan
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Ikeda, Osaka, Japan
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Izumisano, Osaka, Japan
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Kaizuka, Osaka, Japan
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Kishiwada, Osaka, Japan
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Matsubara, Osaka, Japan
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Minoo, Osaka, Japan
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Motiguchi, Osaka, Japan
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Neyagawa, Osaka, Japan
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Osaka Sayama, Osaka, Japan
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Sakai, Osaka, Japan
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Suita, Osaka, Japan
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Toyonaka, Osaka, Japan
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Yao, Osaka, Japan
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Saitama
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Asagiri, Saitama, Japan
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Hidaka, Saitama, Japan
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Kawagoe, Saitama, Japan
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Koshigaya, Saitama, Japan
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Kumagaya, Saitama, Japan
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Sayama, Saitama, Japan
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Shimane
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Hamada, Shimane, Japan
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Shizuoka
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Fuji, Shizuoka, Japan
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Fujieda, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Izu, Shizuoka, Japan
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Shimizu, Shizuoka, Japan
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Tochigi
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Ashikaga, Tochigi, Japan
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Tokushima
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Yoshinogawa, Tokushima, Japan
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Tokyo
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Adachi, Tokyo, Japan
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Arakawa, Tokyo, Japan
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Chiyoda, Tokyo, Japan
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Edogawa, Tokyo, Japan
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Itabashi, Tokyo, Japan
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Katsushika, Tokyo, Japan
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Koutou, Tokyo, Japan
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Minato, Tokyo, Japan
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Musashino, Tokyo, Japan
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Nakano, Tokyo, Japan
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Nishi Tokyo, Tokyo, Japan
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Oota, Tokyo, Japan
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Ota, Tokyo, Japan
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Setagaya, Tokyo, Japan
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Shibuya, Tokyo, Japan
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Shinagawa, Tokyo, Japan
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Shinjyuku, Tokyo, Japan
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Sumida, Tokyo, Japan
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Tachikawa, Tokyo, Japan
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Toshima, Tokyo, Japan
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Toyama
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Kurobe, Toyama, Japan
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Takaoka, Toyama, Japan
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Yamagata
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Kahoku, Yamagata, Japan
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Yamanashi
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Kai, Yamanashi, Japan
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Nirasaki, Yamanashi, Japan
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration)
Beskrivelse
Inclusion Criteria:
- Prostate cancer patients who have no history of receiving endocrine therapy (including surgical castration), and who plan to undergo Casodex® tablets monotherapy for not less than 12 months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Adverse event incidence
Tidsramme: Time since starting Casodex monotherapy, monthly
|
Time since starting Casodex monotherapy, monthly
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
improvement of prostate cancer using Tumor marker PSA
Tidsramme: Time since starting Casodex monotherapy, monthly
|
Time since starting Casodex monotherapy, monthly
|
|
Maintenance of sexual function
Tidsramme: At 3 months since starting Casodex monotherapy,
|
At 3 months since starting Casodex monotherapy,
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2009
Primær færdiggørelse (Faktiske)
1. marts 2012
Studieafslutning (Faktiske)
1. marts 2012
Datoer for studieregistrering
Først indsendt
11. juni 2009
Først indsendt, der opfyldte QC-kriterier
11. juni 2009
Først opslået (Skøn)
12. juni 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. januar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. januar 2013
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIS-OJP-CAS-2009/1
- CAS002
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .