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.

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