Clinical trial NCT00919477: Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg
Official title: Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate cancer
Casodex
Monotherapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 712
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration)

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Adverse event incidence
timeFrame: Time since starting Casodex monotherapy, monthly
Secondary outcomes:
measure: improvement of prostate cancer using Tumor marker PSA
timeFrame: Time since starting Casodex monotherapy, monthly
measure: Maintenance of sexual function
timeFrame: At 3 months since starting Casodex monotherapy,
Other outcomes:
Locations:
city: Houmei
country: Japan
facility: Research Site
state: Aichi
city: Inuyama
country: Japan
facility: Research Site
state: Aichi
city: Kasugai
country: Japan
facility: Research Site
state: Aichi
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Okazaki
country: Japan
facility: Research Site
state: Aichi
city: Toyohashi
country: Japan
facility: Research Site
state: Aichi
city: Toyota
country: Japan
facility: Research Site
state: Aichi
city: Odate
country: Japan
facility: Research Site
state: Akita
city: Hirosaki
country: Japan
facility: Research Site
state: Aomori
city: Asahi
country: Japan
facility: Research Site
state: Chiba
city: Funahashi
country: Japan
facility: Research Site
state: Chiba
city: Ichihara
country: Japan
facility: Research Site
state: Chiba
city: Ichikawa
country: Japan
facility: Research Site
state: Chiba
city: Narashino
country: Japan
facility: Research Site
state: Chiba
city: Sakura
country: Japan
facility: Research Site
state: Chiba
city: Imabari
country: Japan
facility: Research Site
state: Ehime
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Niihama
country: Japan
facility: Research Site
state: Ehime
city: Uwajima
country: Japan
facility: Research Site
state: Ehime
city: Chikushino
country: Japan
facility: Research Site
state: Fukuoka
city: Iizuka
country: Japan
facility: Research Site
state: Fukuoka
city: Kasuga
country: Japan
facility: Research Site
state: Fukuoka
city: Kita Kyushu
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume
country: Japan
facility: Research Site
state: Fukuoka
city: Yukuhashi
country: Japan
facility: Research Site
state: Fukuoka
city: Aizuwakamatsu
country: Japan
facility: Research Site
state: Fukushima
city: Ibi
country: Japan
facility: Research Site
state: Gifu
city: Kani
country: Japan
facility: Research Site
state: Gifu
city: Minokamo
country: Japan
facility: Research Site
state: Gifu
city: Mizunami
country: Japan
facility: Research Site
state: Gifu
city: Ogaki
country: Japan
facility: Research Site
state: Gifu
city: Seki
country: Japan
facility: Research Site
state: Gifu
city: Yamagata
country: Japan
facility: Research Site
state: Gifu
city: Yourou
country: Japan
facility: Research Site
state: Gifu
city: Isesaki
country: Japan
facility: Research Site
state: Gunma
city: Kiryu
country: Japan
facility: Research Site
state: Gunma
city: Numata
country: Japan
facility: Research Site
state: Gunma
city: Ohta
country: Japan
facility: Research Site
state: Gunma
city: Takasaki
country: Japan
facility: Research Site
state: Gunma
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Eniwa
country: Japan
facility: Research Site
state: Hokkaido
city: Kushiro
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Sunagawa
country: Japan
facility: Research Site
state: Hokkaido
city: Tomakomai
country: Japan
facility: Research Site
state: Hokkaido
city: Akashi
country: Japan
facility: Research Site
state: Hyogo
city: Katou
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Takarazuka
country: Japan
facility: Research Site
state: Hyogo
city: Hitachi
country: Japan
facility: Research Site
state: Ibaraki
city: Mito
country: Japan
facility: Research Site
state: Ibaraki
city: Sashima
country: Japan
facility: Research Site
state: Ibaraki
city: Toride
country: Japan
facility: Research Site
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Research Site
state: Ibaraki
city: Hakusan
country: Japan
facility: Research Site
state: Ishihawa
city: Ichinoseki
country: Japan
facility: Research Site
state: Iwate
city: Kamaishi
country: Japan
facility: Research Site
state: Iwate
city: Miyako
country: Japan
facility: Research Site
state: Iwate
city: Morioka
country: Japan
facility: Research Site
state: Iwate
city: Shiwa
country: Japan
facility: Research Site
state: Iwate
city: Takamatsu
country: Japan
facility: Research Site
state: Kagawa
city: Zentrsuji
country: Japan
facility: Research Site
state: Kagawa
city: Minami Satsuma
country: Japan
facility: Research Site
state: Kagoshima
city: Atsugi
country: Japan
facility: Research Site
state: Kanagawa
city: Chigasaki
country: Japan
facility: Research Site
state: Kanagawa
city: Ebina
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki
country: Japan
facility: Research Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Research Site
state: Kanagawa
city: Yamato
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Yokosuka
country: Japan
facility: Research Site
state: Kanagawa
city: Nantan
country: Japan
facility: Research Site
state: Kyoto
city: Inabe
country: Japan
facility: Research Site
state: Mie
city: Tsu
country: Japan
facility: Research Site
state: Mie
city: Matsushima
country: Japan
facility: Research Site
state: Miyagi
city: Natori
country: Japan
facility: Research Site
state: Miyagi
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Shiogama
country: Japan
facility: Research Site
state: Miyagi
city: Tagajo
country: Japan
facility: Research Site
state: Miyagi
city: Isahaya
country: Japan
facility: Research Site
state: Nagasaki
city: Sasebo
country: Japan
facility: Research Site
state: Nagasaki
city: Ikoma
country: Japan
facility: Research Site
state: Nara
city: Kashiba
country: Japan
facility: Research Site
state: Nara
city: Gosen
country: Japan
facility: Research Site
state: Niigata
city: Tsubame
country: Japan
facility: Research Site
state: Niigata
city: Nakatsu
country: Japan
facility: Research Site
state: Oita
city: Kurashiki
country: Japan
facility: Research Site
state: Okayama
city: Habikino
country: Japan
facility: Research Site
state: Osaka
city: Ibaraki
country: Japan
facility: Research Site
state: Osaka
city: Ikeda
country: Japan
facility: Research Site
state: Osaka
city: Izumisano
country: Japan
facility: Research Site
state: Osaka
city: Kaizuka
country: Japan
facility: Research Site
state: Osaka
city: Kishiwada
country: Japan
facility: Research Site
state: Osaka
city: Matsubara
country: Japan
facility: Research Site
state: Osaka
city: Minoo
country: Japan
facility: Research Site
state: Osaka
city: Motiguchi
country: Japan
facility: Research Site
state: Osaka
city: Neyagawa
country: Japan
facility: Research Site
state: Osaka
city: Osaka Sayama
country: Japan
facility: Research Site
state: Osaka
city: Sakai
country: Japan
facility: Research Site
state: Osaka
city: Suita
country: Japan
facility: Research Site
state: Osaka
city: Toyonaka
country: Japan
facility: Research Site
state: Osaka
city: Yao
country: Japan
facility: Research Site
state: Osaka
city: Asagiri
country: Japan
facility: Research Site
state: Saitama
city: Hidaka
country: Japan
facility: Research Site
state: Saitama
city: Kawagoe
country: Japan
facility: Research Site
state: Saitama
city: Koshigaya
country: Japan
facility: Research Site
state: Saitama
city: Kumagaya
country: Japan
facility: Research Site
state: Saitama
city: Sayama
country: Japan
facility: Research Site
state: Saitama
city: Hamada
country: Japan
facility: Research Site
state: Shimane
city: Fujieda
country: Japan
facility: Research Site
state: Shizuoka
city: Fuji
country: Japan
facility: Research Site
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Research Site
state: Shizuoka
city: Izu
country: Japan
facility: Research Site
state: Shizuoka
city: Shimizu
country: Japan
facility: Research Site
state: Shizuoka
city: Ashikaga
country: Japan
facility: Research Site
state: Tochigi
city: Yoshinogawa
country: Japan
facility: Research Site
state: Tokushima
city: Adachi
country: Japan
facility: Research Site
state: Tokyo
city: Arakawa
country: Japan
facility: Research Site
state: Tokyo
city: Chiyoda
country: Japan
facility: Research Site
state: Tokyo
city: Edogawa
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi
country: Japan
facility: Research Site
state: Tokyo
city: Katsushika
country: Japan
facility: Research Site
state: Tokyo
city: Koutou
country: Japan
facility: Research Site
state: Tokyo
city: Minato
country: Japan
facility: Research Site
state: Tokyo
city: Musashino
country: Japan
facility: Research Site
state: Tokyo
city: Nakano
country: Japan
facility: Research Site
state: Tokyo
city: Nishi Tokyo
country: Japan
facility: Research Site
state: Tokyo
city: Oota
country: Japan
facility: Research Site
state: Tokyo
city: Ota
country: Japan
facility: Research Site
state: Tokyo
city: Setagaya
country: Japan
facility: Research Site
state: Tokyo
city: Shibuya
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa
country: Japan
facility: Research Site
state: Tokyo
city: Shinjyuku
country: Japan
facility: Research Site
state: Tokyo
city: Sumida
country: Japan
facility: Research Site
state: Tokyo
city: Tachikawa
country: Japan
facility: Research Site
state: Tokyo
city: Toshima
country: Japan
facility: Research Site
state: Tokyo
city: Kurobe
country: Japan
facility: Research Site
state: Toyama
city: Takaoka
country: Japan
facility: Research Site
state: Toyama
city: Kahoku
country: Japan
facility: Research Site
state: Yamagata
city: Kai
country: Japan
facility: Research Site
state: Yamanashi
city: Nirasaki
country: Japan
facility: Research Site
state: Yamanashi
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
Study officials:
References: