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

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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).

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

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To compare clinical outcomes between robot assisted laparoscopic prostatectomy (RALP) and open retropubic prostatectomy (ORP).

Outcome Description:

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).

Outcome Time Frame:

Eligible participants will initially be followed for 2 years with the possibility for up to 12 years.

Safety Issue:


Principal Investigator

Martin Sanda, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatectomy
  • Prostatic Neoplasms



University of MichiganAnn Arbor, Michigan  48109-0624
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Brigham and Women's HospitalBoston, Massachusetts  02115
University of California, San FranciscoSan Francisco, California  94143
Vanderbilt UniversityNashville, Tennessee  37232-6305
Cleveland ClinicCleveland, Ohio  44195
Johns HopkinsBaltimore, Maryland  21231
Washington University Medical Center St. LouisSt. Louis, Missouri  63110