NCT01296217

Brief Summary

In this study the investigators want to determine if the detection of lymph node is applicable in prostatectomy by laparoscopy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
Last Updated

March 4, 2011

Status Verified

February 1, 2011

First QC Date

February 11, 2011

Last Update Submit

March 3, 2011

Conditions

Prostatic Neoplasms

Keywords

Patients with infiltrant prostatic carcinoma

Outcome Measures

Primary Outcomes (1)

  • detection rate and false-negative rate for the sentinel lymph node detection

    The day of at laparoscopy (Day 1)

Study Arms (1)

lymph nod detection

EXPERIMENTAL
Procedure: lymph nod detection

Interventions

lymph nod detectionPROCEDURE
lymph nod detection

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\> 18 years
  • Diagnosis of invasive cancer of the prostate (T1 or T2 or T3)
  • PSA ≥ 4,
  • Gleason ≥ 6
  • No treatment prior to surgery
  • Indication of lymphadenectomy by coeliscopique
  • ECOG or Karnofsky index 2
  • Patient information and signed informed consent

You may not qualify if:

  • neoadjuvant hormone therapy
  • Interventions prior pelvic
  • Patients who received anterior resection of part of prostate
  • Patient or denied having an altered mental status
  • Any contre indication to laparoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre René Gauducheau

Nantes, 44805, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 15, 2011

Last Updated

March 4, 2011

Record last verified: 2011-02

Locations

FR(1)