Trial Information

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

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.