Clinical trial NCT00922818: Study of Anatomic Nerve Sparing Radical Perineal Prostatectomy
Official title: Clinical Outcomes for Anatomic Nerve Sparing Radical Perineal Prostatectomy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Keywords: Perineal
Prostatectomy
Nerve
Anatomic
Surgery
Neoplasms, Prostatic
Prostate Cancer
Prostate Neoplasms
Prostatic Cancer
Prostate
Cancer
Recurrent
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing anatomic perineal prostatectomy at Maimonides Medical Center

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Perineal prostatectomy for prostate cancer at Maimonides Medical Center

Exclusion Criteria:

* Dementia

Primary outcomes:
measure: Surgical margin-free rate
timeFrame: June 2011
Secondary outcomes:
measure: EPIC-26 Functional Outcome Status
timeFrame: June 2011
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Jason B. Wynberg, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: