Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy

Prostate Cancer Clinical Trial

Official title:

Prospective Assessment of Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578123
• Other study ID #: 04-094
• Status: Completed
• Phase: N/A
• Start date: July 2005
• Est. completion date: June 3, 2022

Study information

• Verified date: June 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 959
• Est. completion date: June 3, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year
Secondary	To evaluate the recovery of continence after RALP or ORP.		2 years
Secondary	To evaluate patient convalescence after RALP or ORP.		2 years
Secondary	To evaluate operative details.	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
Secondary	To evaluate inpatient (hospital) details	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
Secondary	To evaluate post-discharge (home) details.	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
Secondary	To evaluate health service utilization, out-of-pocket spending and changes in employment following RALP or ORP.		2 years

External Links

•   Memorial Sloan-Kettering Cancer Center