Study of Anatomic Nerve Sparing Radical Perineal Prostatectomy (RPP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Maimonides Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT00922818
First received: June 16, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • Surgical margin-free rate [ Time Frame: June 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

Patients undergoing anatomic perineal prostatectomy at Maimonides Medical Center

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922818

Contacts
Contact: Jason B. Wynberg, MD, FACS 718-283-6156 jwynberg@maimonidesmed.org
Contact: David A. Silver, MD, FACS 718-283-7153 dsilver@maimonidesmed.org

Locations
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         
Sponsors and Collaborators
Maimonides Medical Center
Investigators
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 August 28, 2014