An observational study in Prostate Cancer, sponsored by Beth Israel Deaconess Medical Center. Completed at 9 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Beth Israel Deaconess Medical Center · Observational
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).
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.
This study's enrollment of 677 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with localized prostate cancer who have elected to undergo a robot assisted laparoscopic prostatectomy or an open prostatectomy from participating clinical sites
Exclusion Criteria:
Other: Questionnaire
Questionnaire, telephone interviews, and clinical follow-up
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).
Time frame: 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.
Time frame: Eligible participants will initially be followed for 2 years with the possibility for up to 12 years.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center