We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00919477
First Posted: June 12, 2009
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse event incidence [ Time Frame: Time since starting Casodex monotherapy, monthly ]

Secondary Outcome Measures:
  • 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, ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919477


  Show 161 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00919477     History of Changes
Other Study ID Numbers: NIS-OJP-CAS-2009/1
CAS002
First Submitted: June 11, 2009
First Posted: June 12, 2009
Last Update Posted: January 23, 2013
Last Verified: January 2013

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
Antineoplastic Agents