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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00523484

Acronym

CHAMPION

Enrollment

1200

Registered

2007-08-31

Start date

2007-05-31

Completion date

Unknown

Last updated

2010-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Beck Anxiety Inventory, Prostate Cancer, Prostate Specific Antigen, Naturalistic, Observational

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

South Korea

Outcome results