Effectiveness of Open and Robotic Prostatectomy



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/28/2018
Start Date:September 2010
End Date:February 2020

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Effectiveness of Open and Robotic Prostatectomy: The PROSTQA-RP2 Study

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.

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 years.

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).

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
9
sites
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30322
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Atlanta, GA
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Baltimore, Maryland 21218
(410) 516-8000
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Baltimore, MD
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1 Barnes Jewish Hospital Plaza
Saint Louis, Missouri 63110
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Saint Louis, MO
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San Francisco, California 94143
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San Francisco, CA
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