- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00578123
Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy
June 7, 2022 updated by: Memorial Sloan Kettering Cancer Center
Prospective Assessment of Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
959
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1 Questionnaire
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the recovery of continence after RALP or ORP.
Time Frame: 2 years
|
2 years
|
|
To evaluate patient convalescence after RALP or ORP.
Time Frame: 2 years
|
2 years
|
|
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
|
2 years
|
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.
|
2 years
|
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.
|
2 years
|
To evaluate health service utilization, out-of-pocket spending and changes in employment following RALP or ORP.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
June 3, 2022
Study Completion (Actual)
June 3, 2022
Study Registration Dates
First Submitted
December 18, 2007
First Submitted That Met QC Criteria
December 19, 2007
First Posted (Estimate)
December 20, 2007
Study Record Updates
Last Update Posted (Actual)
June 8, 2022
Last Update Submitted That Met QC Criteria
June 7, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 04-094
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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