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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00777452
First received: October 21, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Quality of Life Study in Men With Clinically Localized Prostate Carcinoma Treated With Different Treatment Modalities

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Health-related quality of life changes over time [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urinary symptom score and erectile function over time [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: March 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
active surveillance
2
radical prostatectomy
3
external beam radiotherapy
4
high intensity focused ultrasound

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.

  Eligibility

Ages Eligible for Study:   43 Years to 82 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with clinically localized prostate cancer at single tertiary institution

Criteria

Inclusion Criteria:

  • patients diagnosed with clinically localized prostate cancer

Exclusion Criteria:

  • patients with another malignancies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777452

Locations
Korea, Republic of
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Han Yong Choi, professor Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
  More Information

Publications:
Responsible Party: Choi Han Yong, Samsung Medical Center,Sungkyunkwan University School of Medicine
ClinicalTrials.gov Identifier: NCT00777452     History of Changes
Other Study ID Numbers: SMC IRB 2004-05-21, CRS104-10-4
Study First Received: October 21, 2008
Last Updated: October 21, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
quality of life
localized prostate cancer
FACT-P

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014