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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00919477
First received: June 11, 2009
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 ]

Enrollment: 712
Study Start Date: May 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919477

  Show 161 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00919477     History of Changes
Other Study ID Numbers: NIS-OJP-CAS-2009/1, CAS002
Study First Received: June 11, 2009
Last Updated: January 21, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by AstraZeneca:
Prostate cancer
Casodex
Monotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
 Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013