Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg

Prostate Cancer Clinical Trial

— CAMON  

Official title:

Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919477
• Other study ID #: NIS-OJP-CAS-2009/1
• Secondary ID: CAS002
• Status: Completed
• Phase: N/A
• First received: June 11, 2009
• Last updated: January 21, 2013
• Start date: May 2009
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event incidence		Time since starting Casodex monotherapy, monthly	Yes
Secondary	improvement of prostate cancer using Tumor marker PSA		Time since starting Casodex monotherapy, monthly	No
Secondary	Maintenance of sexual function		At 3 months since starting Casodex monotherapy,	Yes