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Quality of Life Following Radical Prostatectomy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00373308
Recruitment Status : Recruiting
First Posted : September 8, 2006
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will utilize the Expanded Prostate Cancer Index Composite questionnaire to learn what impact the surgery has upon the participant's sense of health, sexual and urinary quality of life.

Condition or disease
Prostatic Neoplasms Prostate Cancer

Detailed Description:
To define impact on quality of life issues for patients undergoing radical prostatectomy. This study will distribute a questionnaire to patients who are being scheduled for radical prostatectomy, both before and after surgery, to assess the impact on quality of life issues. This will provide important information regarding the temporal return of issues pertaining to quality of life.

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Quality of Life Following Radical Prostatectomy
Study Start Date : September 2002
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. urinary and bowel habits [ Time Frame: before and after surgery ]
  2. sexual and hormonal index as self-reported in the questionnaires [ Time Frame: before and after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled to undergo radical prostatectomy at Stanford
Criteria

Inclusion Criteria:

- Patients scheduled to undergo radical prostatectomy at Stanford

Exclusion Criteria:

- Patients treated with neoadjuvant or adjuvant hormonal therapy or radiation therapy

Contacts and Locations

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): NCT00373308


Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Denise Haas    650-736-1252    dhaas@stanford.edu   
Principal Investigator: Benjamin I Chung         
Sub-Investigator: James D Brooks         
Sub-Investigator: Harcharan Gill         
Sub-Investigator: Mark Gonzalgo         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Benjamin I Chung Stanford University
More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00373308     History of Changes
Other Study ID Numbers: PROS0012
78463 ( Other Identifier: Stanford University Alternate IRB Approval Number )
PROS0012 ( Other Identifier: Stanford University )
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016

Keywords provided by Stanford University:
Quality of Life

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