Study of Anatomic Nerve Sparing Radical Perineal Prostatectomy
Conditions
Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
Perineal, Prostatectomy, Nerve, Anatomic, Surgery, Neoplasms, Prostatic, Prostate Cancer, Prostate Neoplasms, Prostatic Cancer, Prostate, Cancer, Recurrent
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
Our objective is to evaluate the clinical outcomes for the anatomic radical perineal prostatectomy (RPP) for the surgical management of prostate cancer. We will report the perioperative, oncologic, and functional outcomes in patients undergoing the radical perineal prostatectomy at our institution.
Detailed Description
The purpose of our study is to evaluate perioperative, oncologic, and functional outcomes for the anatomic radical perineal prostatectomy. The anatomic radical perineal prostatectomy is standard-of-care surgical approach to the surgical management of localized prostate cancer. The operative technique selected for radical prostatectomy is largely based on patient preference after appropriate counseling, and surgeon recommendation based on surgical considerations and surgeon experience. Outcome data for the anatomic radical perineal prostatectomy will represent a valuable addition to the published body of literature. Our study is a prospective clinical outcome data collection and analysis and we will be looking at data within several domains. First, perioperative data will be collected to evaluate the OR time, blood loss, surgical complications, and length of hospital stay for the anatomic radical perineal prostatectomy. Second, oncologic efficacy of this procedure will be reported, based on margin status of surgical specimens, which will be correlated with tumor features (Gleason score, tumor volume, pre-op PSA score). Third, functional outcomes will be evaluated by comparing urinary, sexual, and bowel function in the pre-op and post-op settings. This third domain will be accomplished by employing the following validated questionnaires (attached - SHIM, IPSS, and EPIC-26). These questionnaires will be filled out at 3 time-points: pre-op, and at 3 months and 12 months post-operatively.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Male
Criteria: Inclusion Criteria:

- 18 years of age

- Perineal prostatectomy for prostate cancer at Maimonides Medical Center

Exclusion Criteria:

- Dementia
Location
Maimonides Medical Center
Brooklyn, New York, United States
Status: Recruiting
Contact: Jason B. Wynberg, MD, FACS - 718-283-6156 - jwynberg@maimonidesmed.org
Start Date
June 2009
Completion Date
June 2012
Sponsors
Maimonides Medical Center
Source
Maimonides Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page