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

January 21, 2013 updated by: 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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

712

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse event incidence
Time Frame: Time since starting Casodex monotherapy, monthly
Time since starting Casodex monotherapy, monthly

Secondary Outcome Measures

Outcome Measure
Time Frame
improvement of prostate cancer using Tumor marker PSA
Time Frame: Time since starting Casodex monotherapy, monthly
Time since starting Casodex monotherapy, monthly
Maintenance of sexual function
Time Frame: At 3 months since starting Casodex monotherapy,
At 3 months since starting Casodex monotherapy,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 21, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OJP-CAS-2009/1
  • CAS002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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