Study of Anatomic Nerve Sparing Radical Perineal Prostatectomy (RPP)

August 16, 2018 updated by: Maimonides Medical Center

Clinical Outcomes for Anatomic Nerve Sparing Radical Perineal Prostatectomy

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.

Study Overview

Status

Withdrawn

Conditions

Prostate Cancer

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - Brooklyn, New York, United States, 11219
    - Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing anatomic perineal prostatectomy at Maimonides Medical Center

Description

Inclusion Criteria:

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

Exclusion Criteria:

Dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Radical perineal prostatectomy patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical margin-free rate Time Frame: June 2011	proportion of negative margins	June 2011

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EPIC-26 Functional Outcome Status Time Frame: June 2011	validated outcome questionnaire	June 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimonides Medical Center

Investigators

Principal Investigator: Jason B. Wynberg, MD, FACS, Maimonides Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 26, 2011

Study Completion (Actual)

May 26, 2011

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria