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

Open (Enrolling)
Prostate Cancer, Quality of Life

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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.

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

James Eastham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2005

Completion Date:

July 2013

Related Keywords:

  • Prostate Cancer
  • Quality of Life
  • Prostate
  • Cancer
  • Quality of Life
  • Questionaires
  • 04-094
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021