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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.
Information provided by:
AstraZeneca Identifier:
First received: August 30, 2007
Last updated: January 25, 2010
Last verified: January 2010
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.

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)

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00523484

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
Study Director: Miyoung Kim AstraZeneca Korea
  More Information

Additional Information:
Responsible Party: MC CD, AstraZeneca Identifier: NCT00523484     History of Changes
Other Study ID Numbers: NIS-OKR-CAS-2007/1
Study First Received: August 30, 2007
Last Updated: January 25, 2010

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on June 23, 2017