Casodex/Zoladex Hormonal therApy Study for assessMent of Correlation Between PSA & BAI in prOstate Cancer patieNts - Full Text View

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

This study is ongoing, but not recruiting participants.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00523484

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

MedlinePlus related topics:

Anxiety Cancer Prostate Cancer

ChemIDplus related topics:

Goserelin Bicalutamide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective

Official Title:	An Observational Study to Assess Correlation Between Prostate Specific Antigen & Beck Anxiety Index in Prostate Cancer Patients Under Hormonal Therapy

Further study details as provided by AstraZeneca:

Estimated Enrollment:	1200
Study Start Date:	May 2007
Estimated Study Completion Date:	April 2009

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of written informed consent
Patients who take PSA test regularly
Observation suitable patients for PSA change according to hormonal treatment at least for 6months
Locally advanced or advanced prostate cancer patients who is suitable for hormonal therapy
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:

Prohibition use under permitted indication
Previous inclusion in the present study
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, Anyang-si Dongan-gu
	Research Site
	Kyunggi, Anyang-si Dongan-gu, Korea, Republic of

Korea, Republic of, Jongro-gu
	Research Site
	Seoul, Jongro-gu, Korea, Republic of

Korea, Republic of, Songpa-gu
	Research Site
	Seoul, Songpa-gu, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Miyoung Kim	AstraZeneca Korea

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	NIS-OKR-CAS-2007/2
First Received:	August 30, 2007
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00523484
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

Beck Anxiety Inventory

Prostate Cancer

Prostate Specific Antigen

Naturalistic

Observational

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Goserelin

Bicalutamide

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008