Effectiveness of Open and Robotic Prostatectomy

Completed

Conditions studied: Prostate Cancer

In brief

Prostate cancer is the most common cancer in American men. Surgical removal of the entire prostate (prostatectomy) is one option among the various ways to treat prostate cancer. The use of robot assistance for prostatectomy has become common place, but its effectiveness has not been compared to standard open prostatectomy in trials carried out at more than one medical institution in which participants are identified and followed forward in time. Robot assisted and standard open prostatectomy health related quality of life (HRQOL) outcomes have not been compared in a prospective, multi-centered study. Prostatectomy can have side effects that can change with time. This research study seeks to determine how common and how long-lasting such side effects are; to find out what features of individual men's cancers and what features of the treatments affect those side effects. This study also seeks to identify factors that affect the quality of prostate cancer care by looking at how satisfied men are with their prostate cancer care. Through these findings, this study aims to allow treatment side effects to be anticipated more accurately for individual patients, and to provide a means for determining the quality of prostate care.

Key facts

Study ID

NCT01325506

Run by

Beth Israel Deaconess Medical Center

People needed

677

Starts

2010-09-01

Expected to finish

2024-10-01

Last updated by the study team

2024-11-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Early stage prostate cancer (AJCC [2002] clinical stage < or = T2NXMX; T stage is based on rectal exam findings alone).
• Gleason score based on local pathology within 12 months of registration. (Patients with an original diagnosis of prostate cancer proceeding 12 months are also eligible but pathology confirmation of cancer within 12 months of registration is required.)
• Serum PSA test result from within 12 months of registration
• Able to participate in baseline and follow-up phone interviews conducted in English
• Scheduled to undergo Open Radical Prostatectomy or Robotic Assisted Laparoscopic Prostatectomy

You may not qualify if…

• Previous definitive primary prostate cancer therapy (prostatectomy, external radiation, brachytherapy, cryotherapy, or other interventions)
• Previous radiation therapy to the pelvis
• Previous major reconstructive or extirpative pelvic surgery (including but not limited to abdominal-perineal resection, or penile implant)
• Previous androgen suppression therapy (LHrH agonist or antagonist), anti-androgen therapy (Casodex, Flutamide, or Nilandron), or estrogen therapy (DES or PC-SPEZ). (Prior or current finasteride or dutasteride therapy is allowed)
• Known urethral stricture
• Urostomy or colostomy
• Chronic urinary catheterization

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Emory Healthcare — Atlanta, Georgia, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University Medical Center St. Louis — St Louis, Missouri, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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