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

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Research Site, Houmei, Aichi-ken, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Adverse event incidence

Time frame: Time since starting Casodex monotherapy, monthly

Secondary outcomes

improvement of prostate cancer using Tumor marker PSA

Time frame: Time since starting Casodex monotherapy, monthly
Maintenance of sexual function

Time frame: At 3 months since starting Casodex monotherapy,

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: CAMON

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Jun 12, 2009
Registry last updated: Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed