Effectiveness of Open and Robotic Prostatectomy: The PROSTQA-RP2 Study
18 Years
N/A
Male
Prostate Cancer
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
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
Type of Study:
Observational
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:
No
Principal Investigator
Martin Sanda, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beth Israel Deaconess Medical Center
Authority:
United States: Institutional Review Board
Study ID:
10-155
NCT ID:
NCT01325506
Start Date:
September 2010
Completion Date:
Related Keywords:
- Prostate Cancer
- Prostatectomy
- Prostatic Neoplasms
Name | Location |
|---|---|
| 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 |
