A Prospective Longitudinal Study of Health-Related Quality of Life in Men With Clinically Localized Prostate Cancer

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00777452
• Lead Sponsor: Samsung Medical Center

Brief Summary

to prospectively assess the health-related quality of life (HRQOL) changes during the first year after different treatment modalities for localized prostate cancer.

Detailed Description

Quality of life is of great concern to patients considering treatment options for prostate cancer. Patients with clinically localized prostate cancer treated with active surveillance, radical prostatectomy, external radiotherapy and high intensity focused ultrasound were included. All men completed the questionnaires of Functional Assessment of Cancer Therapy-Prostate (FACT-P) (version 4), International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF) before treatment and 1, 3, 6, 12 months after treatment.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-10
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Last Update Submitted: 2008-10-21
• Study First Posted: 2008-10-22
• Last Update Posted: 2008-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 93

Inclusion Criteria

• patients diagnosed with clinically localized prostate cancer

Exclusion Criteria

• patients with another malignancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-related quality of life changes over time	12 months after treatment

Secondary Outcome Measures

Name	Time	Method
urinary symptom score and erectile function over time	12 months after treatment

Trial Locations

Locations (1)

Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of