NCT01325506Completed
Effectiveness of Open and Robotic Prostatectomy
Effectiveness of Open and Robotic Prostatectomy: The PROSTQA-RP2 Study
Source: ClinicalTrials.gov · Last updated 6 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 677 (actual)
- First submitted
- 9 Mar 2011
- Start date
- Sept 2010
- Primary completion date
- Oct 2024
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT01325506
What you commit to
- Study type: Observational
- Participants enrolled: 677
- From Sept 2010 to the primary completion date, Oct 2024
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other
- Known urethral stricture
- Urostomy or colostomy
- Chronic urinary catheterization
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Emory Healthcare Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Vanderbilt University Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Washington University Medical Center St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.