NCT00169676

Brief Summary

Recently, many centers have begun offering laparoscopic radical prostatectomy (LRP) as a minimally invasive therapy for localized prostate cancer.1-6 LRP may offer the advantages of improved neurovascular bundle sparing, a more precise urethrovesical anastomosis, shorter hospitalization, and decreased convalescence. Our group at Methodist Urology, LLC has extensive experience in laparoscopy and in treating prostate cancer and are planning to offer LRP. We intend to maintain a registry and database to document the outcomes with LRP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 29, 2016

Status Verified

September 1, 2008

Enrollment Period

12.8 years

First QC Date

September 9, 2005

Last Update Submit

June 28, 2016

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • To create a registry and database for the treatment of localized prostate cancer with LRP. To record long term outcomes for patients undergoing Laparoscopic Radical Prostatectomy.

    One year

Study Arms (1)

cohort

Registry and Database

Other: observation

Interventions

observationOTHER

registry and database for surgery outcomes

cohort

Eligibility Criteria

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

Patients of Methodist Urology that are scheduled to undergo a laser procedure for prostate removal

You may qualify if:

  • Patient of Methodist Urology in Indianapolis, IN
  • Ability to give informed consent
  • Biopsy proven diagnosis of prostate cancer without local extension or metastatic disease (Clinical T2 or less in the TNM classification)

You may not qualify if:

  • Major abdominal surgery precluding a safe laparoscopic approach
  • Bleeding diathesis or anticoagulation
  • Medical disease (such as cardiovascular or pulmonary diseases) precluding general anesthesia/laparoscopy
  • Transplanted kidney in the pelvis
  • Radiation therapy to pelvis
  • Morbid obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Larry Munch, MD

    Methodist Urology, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

June 1, 2003

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 29, 2016

Record last verified: 2008-09

Locations

US(1)