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Casodex/Zoladex Hormonal therApy Study for assessMent of Correlation Between PSA & BAI in prOstate Cancer patieNts (CHAMPION)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00523484
First Posted: August 31, 2007
Last Update Posted: January 26, 2010
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:
AstraZeneca
  Purpose
This study is an observational study to see whether anxiety level can be correlated with PSA level under the current practice in the patients of prostate cancer taking hormonal therapy. For assessment of anxiety level BAI(Beck Anxiety Inventory) will be used. The target population for this study is the patients of prostate cancer diagnosed previously and who are taking hormonal therapy with regular follow-up and PSA test. The follow-up duration will be total 6 months with interim visit at 3 month and final visit at 6 month.

Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Assess Correlation Between Prostate Specific Antigen & Beck Anxiety Index in Prostate Cancer Patients Under Hormonal Therapy

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Estimated Enrollment: 1200
Study Start Date: May 2007
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Advanced prostate cancer patients who were being treated by hormonal agents
Criteria

Inclusion Criteria:

  1. Provision of written informed consent
  2. Patients who take PSA test regularly
  3. Observation suitable patients for PSA change according to hormonal treatment at least for 6months
  4. Locally advanced or advanced prostate cancer patients who is suitable for hormonal therapy
  5. Prostate Cancer Patients who has been taking one treatment among 3 hormonal therapies in below:

    • Bicalutamide Monotherapy : Bicalutamide 150mg/day
    • Goserelin 3.6mg/10.8mg
    • MAB(Maximal Androgen Blockade) :Bicalutamide 50mg + Goserelin 3.6/10.8mg

Exclusion Criteria:

  1. Prohibition use under permitted indication
  2. Previous inclusion in the present study
  3. Participation in a clinical study during the last 30 days
  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): NCT00523484


Locations
Korea, Republic of
Research Site
Kyunggi, Anyang-si Dongan-gu, Korea, Republic of
Research Site
Seoul, Jongro-gu, Korea, Republic of
Research Site
Seoul, Songpa-gu, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Miyoung Kim AstraZeneca Korea
  More Information

Additional Information:
Responsible Party: MC CD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00523484     History of Changes
Other Study ID Numbers: NIS-OKR-CAS-2007/1
First Submitted: August 30, 2007
First Posted: August 31, 2007
Last Update Posted: January 26, 2010
Last Verified: January 2010

Keywords provided by AstraZeneca:
Beck Anxiety Inventory
Prostate Cancer
Prostate Specific Antigen
Naturalistic
Observational

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases