NCT00922818

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2011

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

June 16, 2009

Last Update Submit

August 16, 2018

Conditions

Prostate Cancer

Keywords

PerinealProstatectomyNerveAnatomicSurgeryNeoplasms, ProstaticProstate CancerProstate NeoplasmsProstatic CancerProstateCancerRecurrent

Outcome Measures

Primary Outcomes (1)

  • Surgical margin-free rate

    proportion of negative margins

    June 2011

Secondary Outcomes (1)

  • EPIC-26 Functional Outcome Status

    June 2011

Study Arms (1)

Radical perineal prostatectomy patients

Radical perineal prostatectomy patients

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing anatomic perineal prostatectomy at Maimonides Medical Center

You may qualify if:

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

You may not qualify if:

  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jason B. Wynberg, MD, FACS

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 17, 2009

Study Start

June 1, 2009

Primary Completion

May 26, 2011

Study Completion

May 26, 2011

Last Updated

August 20, 2018

Record last verified: 2018-08

Locations

US(1)