NCT00523484

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Last Updated

January 26, 2010

Status Verified

January 1, 2010

Enrollment Period

1.5 years

First QC Date

August 30, 2007

Last Update Submit

January 25, 2010

Conditions

Prostate Cancer

Keywords

Beck Anxiety InventoryProstate CancerProstate Specific AntigenNaturalisticObservational

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Advanced prostate cancer patients who were being treated by hormonal agents

You may qualify if:

  • 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

You may not qualify if:

  • Prohibition use under permitted indication
  • Participation in a clinical study during the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Kyunggi, Anyang-si Dongan-gu, South Korea

Location

Research Site

Seoul, Jongro-gu, South Korea

Location

Research Site

Seoul, Songpa-gu, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Miyoung Kim

    AstraZeneca Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2007

First Posted

August 31, 2007

Study Start

May 1, 2007

Primary Completion

November 1, 2008

Last Updated

January 26, 2010

Record last verified: 2010-01

Locations

KR(3)