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

NCT ID: NCT00523484

Last Updated: 2010-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Miyoung Kim

Role: STUDY_DIRECTOR

AstraZeneca Korea

Locations

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Research Site

Kyunggi, Anyang-si Dongan-gu, South Korea

Site Status

Research Site

Seoul, Jongro-gu, South Korea

Site Status

Research Site

Seoul, Songpa-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NIS-OKR-CAS-2007/1

Identifier Type: -

Identifier Source: org_study_id

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