Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777452
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : October 22, 2008
Sponsor:
Information provided by:
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.

Condition or disease
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 93 participants
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
Study Start Date : March 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
1
active surveillance
2
radical prostatectomy
3
external beam radiotherapy
4
high intensity focused ultrasound



Primary Outcome Measures :
  1. Health-related quality of life changes over time [ Time Frame: 12 months after treatment ]

Secondary Outcome Measures :
  1. urinary symptom score and erectile function over time [ Time Frame: 12 months after treatment ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   43 Years to 82 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777452


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Han Yong Choi, professor Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Publications of Results:
Layout table for additonal information
Responsible Party: Choi Han Yong, Samsung Medical Center,Sungkyunkwan University School of Medicine
ClinicalTrials.gov Identifier: NCT00777452    
Other Study ID Numbers: SMC IRB 2004-05-21
CRS104-10-4
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: October 22, 2008
Last Verified: October 2008
Keywords provided by Samsung Medical Center:
quality of life
localized prostate cancer
FACT-P
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases