Study of Anatomic Nerve Sparing Radical Perineal Prostatectomy (RPP)
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Prostate Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Clinical Outcomes for Anatomic Nerve Sparing Radical Perineal Prostatectomy |
- Surgical margin-free rate [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
- EPIC-26 Functional Outcome Status [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Radical perineal prostatectomy patients
Radical perineal prostatectomy patients
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients undergoing anatomic perineal prostatectomy at Maimonides Medical Center
Inclusion Criteria:
- 18 years of age
- Perineal prostatectomy for prostate cancer at Maimonides Medical Center
Exclusion Criteria:
- Dementia
Contacts and Locations| Contact: Jason B. Wynberg, MD, FACS | 718-283-6156 | jwynberg@maimonidesmed.org |
| Contact: David A. Silver, MD, FACS | 718-283-7153 | dsilver@maimonidesmed.org |
| United States, New York | |
| Maimonides Medical Center | Recruiting |
| Brooklyn, New York, United States, 11219 | |
| Contact: Jason B. Wynberg, MD, FACS 718-283-6156 jwynberg@maimonidesmed.org | |
| Contact: David A. Silver, MD, FACS 718-283-7153 dsilver@maimonidesmed.org | |
| Principal Investigator: Jason B. Wynberg, MD, FACS | |
| Principal Investigator: David A. Silver, MD, FACS | |
| Principal Investigator: | Jason B. Wynberg, MD, FACS | Maimonides Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jason B. Wynberg, MD, FACS, Maimonides Medical Center |
| ClinicalTrials.gov Identifier: | NCT00922818 History of Changes |
| Other Study ID Numbers: | 09-05-VA02 |
| Study First Received: | June 16, 2009 |
| Last Updated: | June 16, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Maimonides Medical Center:
|
Perineal Prostatectomy Nerve Anatomic Surgery Neoplasms, Prostatic |
Prostate Cancer Prostate Neoplasms Prostatic Cancer Prostate Cancer Recurrent |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013