Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg
CAMON
2 other identifiers
observational
712
1 country
160
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Typical duration for all trials
160 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 11, 2009
CompletedFirst Posted
Study publicly available on registry
June 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJanuary 23, 2013
January 1, 2013
2.8 years
June 11, 2009
January 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse event incidence
Time since starting Casodex monotherapy, monthly
Secondary Outcomes (2)
improvement of prostate cancer using Tumor marker PSA
Time since starting Casodex monotherapy, monthly
Maintenance of sexual function
At 3 months since starting Casodex monotherapy,
Eligibility Criteria
Prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration)
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (160)
Research Site
Houmei, Aichi-ken, Japan
Research Site
Inuyama, Aichi-ken, Japan
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Kasugai, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Okazaki, Aichi-ken, Japan
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Toyohashi, Aichi-ken, Japan
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Toyota, Aichi-ken, Japan
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Akita, Akita, Japan
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Ōdate, Akita, Japan
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Hirosaki, Aomori, Japan
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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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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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Chikushino-shi, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Iizuka, Fukuoka, Japan
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Kasuga, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Yukuhashi, Fukuoka, Japan
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Aizu-Wakamatsu, Fukushima, Japan
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Fukushima, Fukushima, Japan
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Gifu, Gifu, Japan
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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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Ōgaki, Gifu, Japan
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Sekimachi, Gifu, Japan
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Yamagata, Gifu, Japan
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Yourou, Gifu, Japan
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Isesaki, Gunma, Japan
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Kiryū, 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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Hiroshima, Hiroshima, Japan
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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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Akashi, Hyōgo, Japan
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Katou, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Takarazuka, Hyōgo, Japan
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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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Hakusan, Ishihawa, Japan
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Hizume, Iwate, Japan
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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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Takamatsu, Kagawa-ken, Japan
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Zentrsuji, Kagawa-ken, Japan
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Minamisatsuma, Kagoshima-ken, Japan
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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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Kochi, Kochi, Japan
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Kumamoto, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Nantan, Kyoto, Japan
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Inabe, Mie-ken, Japan
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Tsu, Mie-ken, Japan
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Matsushima, Miyagi, Japan
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Natori-shi, Miyagi, Japan
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Sendai, Miyagi, Japan
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Shiogama, Miyagi, Japan
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Tagajō-shi, Miyagi, Japan
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Isahaya, Nagasaki, Japan
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Nagasaki, Nagasaki, Japan
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Sasebo, Nagasaki, Japan
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Ikoma, Nara, Japan
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Kashiba, Nara, Japan
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Nara, Nara, Japan
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Gosen, Niigata, Japan
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Tsubame, Niigata, Japan
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Nakatsu, Oita Prefecture, Japan
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Kurashiki, Okayama-ken, Japan
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Okayama, Okayama-ken, Japan
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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, Osaka, Japan
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Ōsaka-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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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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Saitama, Saitama, Japan
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Sayama, Saitama, Japan
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Hamada, Shimane, Japan
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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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Shizuoka, Shizuoka, Japan
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Ashikaga, Tochigi, Japan
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Tokushima, Tokushima, Japan
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Yoshinogawa, Tokushima, Japan
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Adachi City, Tokyo, Japan
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Arakawa City, Tokyo, Japan
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Chiyoda City, Tokyo, Japan
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Edogawa City, Tokyo, Japan
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Katsushika-ku, 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 City, Tokyo, Japan
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Nishitōkyō, Tokyo, Japan
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Oota, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya City, Tokyo, Japan
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Shibuya City, Tokyo, Japan
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Shinagawa, Tokyo, Japan
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Shinjyuku, Tokyo, Japan
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Sumida City, Tokyo, Japan
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tabashi City, Tokyo, Japan
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Tachikawa, Tokyo, Japan
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Toshima City, Tokyo, Japan
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Tottori-shi, Tottori, Japan
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Kurobe-shi, Toyama, Japan
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Takaoka, Toyama, Japan
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Toyama, Toyama, Japan
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Wakayama, Wakayama, Japan
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Yachi, Yamagata, Japan
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Yamagata, Yamagata, Japan
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Kai, Yamanashi, Japan
Research Site
Nirasaki, Yamanashi, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2009
First Posted
June 12, 2009
Study Start
May 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
January 23, 2013
Record last verified: 2013-01