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

Prostate Cancer Clinical Trial

— CHAMPION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523484
• Other study ID #: NIS-OKR-CAS-2007/1
• Status: Completed
• Phase: N/A
• First received: August 30, 2007
• Last updated: January 25, 2010
• Start date: May 2007

Study information

• Verified date: January 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

External Links

•   Link