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

AstraZeneca

Status: Completed

Conditions: Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT00523484

NIS-OKR-CAS-2007/1

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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