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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| The Cleveland Clinic | OTHER |
| Johns Hopkins University | OTHER |
| University of California, San Francisco |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostatectomy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Questionnaire, telephone interviews, and clinical follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| To compare patient-reported outcomes between robot assisted laparoscopic prostatectomy (RALP) and open retropubic prostatectomy (ORP). | Outcomes include: patient-reported outcomes (urinary incontinence, erectile dysfunction) and satisfaction with overall treatment outcome. | Eligible participants will initially be followed for 2 years with the possibility for up to 12 years. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with localized prostate cancer who have elected to undergo a robot assisted laparoscopic prostatectomy or an open prostatectomy from participating clinical sites
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| Name | Affiliation | Role |
|---|---|---|
| Martin Sanda, MD | Emory Healthcare | Principal Investigator |
| Peter Chang, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Emory Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34433304 | Derived | Chang P, Wagner AA, Regan MM, Smith JA, Saigal CS, Litwin MS, Hu JC, Cooperberg MR, Carroll PR, Klein EA, Kibel AS, Andriole GL, Han M, Partin AW, Wood DP, Crociani CM, Greenfield TK, Patil D, Hembroff LA, Davis K, Stork L, Spratt DE, Wei JT, Sanda MG; PROST-QA/RP2 Consortium. Prospective Multicenter Comparison of Open and Robotic Radical Prostatectomy: The PROST-QA/RP2 Consortium. J Urol. 2022 Jan;207(1):127-136. doi: 10.1097/JU.0000000000002176. Epub 2021 Aug 26. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| OTHER |
| University of Michigan | OTHER |
| Vanderbilt University | OTHER |
| Washington University School of Medicine | OTHER |
| Emory University | OTHER |
| Dana-Farber Cancer Institute | OTHER |
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| Atlanta |
| Georgia |
| 30322 |
| United States |
| Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University Medical Center St. Louis | St Louis | Missouri | 63110 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |