Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg (CAMON)
This study has been completed.
Information provided by (Responsible Party):
First received: June 11, 2009
Last updated: January 21, 2013
Last verified: January 2013
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).
||Observational Model: Cohort
Time Perspective: Prospective
||Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg
Primary Outcome Measures:
- Adverse event incidence [ Time Frame: Time since starting Casodex monotherapy, monthly ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- improvement of prostate cancer using Tumor marker PSA [ Time Frame: Time since starting Casodex monotherapy, monthly ] [ Designated as safety issue: No ]
- Maintenance of sexual function [ Time Frame: At 3 months since starting Casodex monotherapy, ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2012 (Final data collection date for primary outcome measure)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration)
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00919477
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 11, 2009
||January 21, 2013
||Japan: Institutional Review Board
Keywords provided by AstraZeneca:
ClinicalTrials.gov processed this record on March 03, 2015