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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center The Cleveland Clinic |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00578123 |
The goal of the study is to look at surgical recovery and quality of life for men who have an open versus laparoscopic radical prostatectomy (RP). RP is a procedure that removes the prostate gland. We want to see how long it will take you to return to health and strength after surgery. Quality-of-life (QOL) means how you feel about your life and your treatment of prostate cancer. The QOL surveys ask questions about your sexual, urinary and bowel functions. We hope that the surveys will help show how prostate cancer treatments affect your daily life after surgery.
Condition | Intervention |
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Prostate Cancer Quality of Life |
Behavioral: Quailty of Life Questionairs |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Single Group Assignment |
Official Title: | Prospective Assessment of Clinical and Quality of Life Outcomes After Open or Laparoscopic Radical Prostatectomy |
Estimated Enrollment: | 450 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 Questionaires
Quality of Life Questionaires
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Behavioral: Quailty of Life Questionairs
Baseline. You will be asked to complete the following three surveys before your surgery. Survey # 1: The Prostate Health-Related Quality-of-Life Survey (PHRQOL) Survey # 2: Brief Pain Inventory (BPI) Survey # 6 : Then Test - Baseline In-patient: Survey # 2: Brief Pain Inventory (BPI) Survey # 3: Post Surgical Recovery, In-Patient Nursing Survey (PSR) Three weeks after your surgery, you will receive the following surveys in the mail: Survey # 2: Brief Pain Inventory (BPI) Survey # 4: Post Surgery Survey (PSS) Survey # 5: The Subjective Significance Survey (SSQ) Survey #8: Urinary and Sexual Function Survey (USF) |
This study will prospectively assess clinical outcomes and changes from baseline in health-related quality of life (HRQOL) in men undergoing open, robotic-assisted, or laparoscopic radical prostatectomy. Open radical prostatectomy is a frequently performed treatment for patients with clinically localized (cT1-T3a) prostate cancer. The open technique stands as a benchmark against which all other treatments, including new surgical techniques, must be compared. Robotic-assisted and laparoscopic radical prostatectomy are considered an alternative surgical option for clinically localized prostate cancer. While these minimally invasive techniques are more frequently being performed in the United States, a detailed comparison of the open and laparoscopic techniques has not been performed. The relative risks and benefits of these surgical treatment options have not been explored in a contemporary group of patients treated at the same center by surgeons experienced in the open, robotic-assisted, or laparoscopic techniques.
This study will address this deficiency in that baseline and follow-up information will be collected prospectively in consecutive patients undergoing open, robotic-assisted, or laparoscopic radical prostatectomy.
While a prospective,randomized trial might be considered a more appropriate methodology to conduct such a comparative study, we have no baseline information, no guidelines to assess robotic-assisted or laparoscopic competence, and a lack of skilled laparoscopic pelvic surgeons to justify a lengthy and expensive trial. While results from our proposed study will not necessarily be generalizable to all surgeons and may very well be a comparison of surgeons rather than techniques, the results will provide an initial assessment comparing experts in the open, robotic-assisted, and laparoscopic techniques. To date, no such comparison has been published. To our knowledge, no other center has expert surgeons in these techniques where such a study would be feasible. Because open techniques have improved dramatically over the past several years, and because the baseline data to be recorded in this proposal is not currently collected, use of historical controls for open radical prostatectomy would be inappropriate.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | James Eastham, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( James Eastham, MD ) |
Study ID Numbers: | 04-094 |
Study First Received: | December 18, 2007 |
Last Updated: | May 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00578123 History of Changes |
Health Authority: | United States: Institutional Review Board |
Prostate Cancer Quality of Life Questionaires |
Prostatic Diseases Genital Neoplasms, Male Quality of Life |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |