Effectiveness of Open and Robotic Prostatectomy: The PROSTQA-RP2 Study
The investigators will follow your prostate cancer treatment outcomes and health related
quality of life following prostatectomy by asking you direct questions, collect information
from medical records and phone interviews.
Information about your prostate cancer treatment, and related health concerns, and
information regarding the cost of care, may also be collected from your medical record,
other medical center sources, and your primary care provider (PCP). Clinical information
will be collected: prior to beginning treatment (prostatectomy); 6 month, 12 months, 18
months, and 24 months after your prostatectomy; once a year thereafter for possibly up to 12
You will be asked to take part in six telephone interviews regarding quality of life,
possible therapy side effects, and satisfaction with prostate cancer therapy. Each phone
interview should last 15-25 minutes. All questions are voluntary. The phone interviews will
be conducted: prior to beginning treatment (prostatectomy); 2 months, 6 months, 12 months,
18 months, and 24 months after prostatectomy; 10 additional phone interviews may be
conducted (once a year thereafter, for possibly up to 12 years).
Observational Model: Cohort, Time Perspective: Prospective
To compare clinical outcomes between robot assisted laparoscopic prostatectomy (RALP) and open retropubic prostatectomy (ORP).
Outcomes include: acute clinical morbidity (thromboembolic events, bleeding requiring transfusion, surgical infection, other events requiring intervention within 30 days of prostatectomy) and satisfaction with overall treatment outcome; cancer control (surgical margins, PSA recurrence-free survival, requirement of salvage or adjuvant treatment).
Eligible participants will initially be followed for 2 years with the possibility for up to 12 years.
Martin Sanda, MD
Beth Israel Deaconess Medical Center
United States: Institutional Review Board
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|University of California, San Francisco||San Francisco, California 94143|
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|Cleveland Clinic||Cleveland, Ohio 44195|
|Johns Hopkins||Baltimore, Maryland 21231|
|Washington University Medical Center St. Louis||St. Louis, Missouri 63110|