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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00523484
First received: August 30, 2007
Last updated: January 25, 2010
Last verified: January 2010
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MC CD, AstraZeneca
ClinicalTrials.gov 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
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013