Full Text View
Tabular View
No Study Results Posted
Related Studies
Clinical and Quality of Life Outcomes After Open or Laparoscopic Radical Prostatectomy
This study is ongoing, but not recruiting participants.
First Received: December 18, 2007   Last Updated: May 15, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
The Cleveland Clinic
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00578123
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To compare robotic-assisted radical prostatectomy (RALP), laparoscopic radical prostatectomy (LRP), and open radical prostatectomy (ORP) with respect to potency function at 2 years, after adjusting for known confounding variables measured at baseline. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the recovery of continence after RALP, ORP or LRP. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
1 Questionaires
Quality of Life Questionaires
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)


Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven adenocarcinoma of the prostate
  • Clinical stage T1-3a, NX or N0, Mx or M0
  • Life expectancy greater than or equal to 10 years
  • Planned radical prostatectomy
  • Patients must be able to read and speak English, be free of cognitive impairment, and be reachable by telephone

Exclusion Criteria:

  • Prior hormonal therapy for prostate cancer
  • Prior pelvic radiation
  • Prior chemotherapy for prostate cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578123

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
The Cleveland Clinic
Investigators
Principal Investigator: James Eastham, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Prostate
Cancer
Quality of Life
Questionaires

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Quality of Life
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

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

ClinicalTrials.gov processed this record on September 10, 2009