NCT00919477

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
712

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Typical duration for all trials

Geographic Reach
1 country

160 active sites

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

June 11, 2009

Last Update Submit

January 21, 2013

Conditions

Keywords

Prostate cancerCasodexMonotherapy

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

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (160)

Research Site

Houmei, Aichi-ken, Japan

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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

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Nirasaki, Yamanashi, Japan

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

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

Locations