Effectiveness of Open and Robotic Prostatectomy (PROSTQA-RP2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01325506|
Recruitment Status : Active, not recruiting
First Posted : March 29, 2011
Last Update Posted : June 25, 2020
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: Questionnaire|
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).
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Effectiveness of Open and Robotic Prostatectomy: The PROSTQA-RP2 Study|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2024|
Questionnaire, telephone interviews, and clinical follow-up
- To compare clinical outcomes between robot assisted laparoscopic prostatectomy (RALP) and open retropubic prostatectomy (ORP). [ Time Frame: Eligible participants will initially be followed for 2 years with the possibility for up to 12 years. ]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).
- To compare patient-reported outcomes between robot assisted laparoscopic prostatectomy (RALP) and open retropubic prostatectomy (ORP). [ Time Frame: Eligible participants will initially be followed for 2 years with the possibility for up to 12 years. ]Outcomes include: patient-reported outcomes (urinary incontinence, erectile dysfunction) and satisfaction with overall treatment outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325506
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|Washington University Medical Center St. Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Martin Sanda, MD||Emory Healthcare|
|Principal Investigator:||Peter Chang, MD, MPH||Beth Israel Deaconess Medical Center|