Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic 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. Read our disclaimer for details. Identifier: NCT00578123
Recruitment Status : Active, not recruiting
First Posted : December 20, 2007
Last Update Posted : August 4, 2017
The Cleveland Clinic
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The goal of the study is to look at surgical recovery and quality of life for men who have an open versus robotic-assisted 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 will also ask questions about your use of health care services, out-of-pocket-spending on medical care and about your return to work, in order to learn about the financial impact of prostate cancer treatment. We hope that the surveys will help show how prostate cancer treatments affect your daily life after surgery.

Condition or disease Intervention/treatment Phase
Prostate Cancer Quality of Life Behavioral: Quality of Life Questionnaires Not Applicable

Detailed Description:
This study will prospectively assess clinical outcomes in health-related quality of life (HRQOL) in men undergoing open, or robotic-assisted laparoscopic radical prostatectomy. Open radical prostatectomy is a frequently performed treatment for patients with clinically localized (cT1-T2) 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 is considered an alternative surgical option for clinically localized prostate cancer. While this minimally invasive technique is more frequently being performed in the United States, a detailed comparison of the open and robotic-assisted 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 and robotic-assisted laparoscopic techniques. This study will address this deficiency in that follow-up information will be collected prospectively in consecutive patients undergoing open or robotic-assisted 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 laparoscopic competence, and a lack of skilled robotic-assisted laparoscopic pelvic surgeons to justify a lengthy and expensive trial. We will also collect information on health service utilization and employment during the 12-month postoperative period in order to assess the economic impacts of the different surgical approaches. 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 and robotic-assisted 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 959 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Assessment of Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy
Study Start Date : July 2005
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
1 Questionnaire
Quality of Life Questionnaires
Behavioral: Quality of Life Questionnaires
Three surveys you will need to complete. We will give you the surveys during your regularly scheduled clinic visits at three, six, and twelve months after surgery. You will NOT be asked to make additional appointments just for the study. You will have the option of completing some of the surveys in an easy to use computer format in the clinic waiting area or on paper.

Primary Outcome Measures :
  1. To compare robotic-assisted radical prostatectomy (RALP), and open radical prostatectomy (ORP) with respect to potency function at 1 year, after adjusting for known confounding variables measured at baseline. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To evaluate the recovery of continence after RALP or ORP. [ Time Frame: 2 years ]
  2. To evaluate patient convalescence after RALP or ORP. [ Time Frame: 2 years ]
  3. To evaluate operative details. [ Time Frame: 2 years ]
    Including operative time, blood loss, intraoperative fluid requirements, type of anesthesia, number and type of surgical drains, status of the neurovascular bundles including whether or not nerve grafting was performed, incision length, and other ancillary procedures for RALP or ORP

  4. To evaluate inpatient (hospital) details [ Time Frame: 2 years ]
    Including time in the post-anesthesia care unit, hospital convalescence, day of oral intake, day of ambulation, analgesia requirements, daily weights, length of time and output from surgical drains, hemoglobin and creatinine, complications, and length of hospital stay.

  5. To evaluate post-discharge (home) details. [ Time Frame: 2 years ]
    Including analgesic use, return to normal activities/work, time of urinary catheterization, need for catheter replacement, hemoglobin, complications, visit to emergency room or unscheduled clinic visits, and biochemical outcomes (serum PSA levels) following surgery.

  6. To evaluate health service utilization, out-of-pocket spending and changes in employment following RALP or ORP. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Biopsy proven adenocarcinoma of the prostate
  • Clinical stage T1-T2, 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

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 identifier (NCT number): NCT00578123

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
Principal Investigator: James Eastham, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00578123     History of Changes
Other Study ID Numbers: 04-094
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

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