Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer (SENTINELLE)

May 23, 2023 updated by: Assistance Publique Hopitaux De Marseille
The diagnosis of a ganglionic infringement(achievement) at a patient reached (affected) by a prostate cancer is a factor(mailman) of bad forecast. The locoregional ganglionic staging is a very important element in the coverage (care). He allows to determine the local extension of the disease and the type(chap) of therapeutics to implement(operate) after the surgery. The standard cleaning out at present recommended by the European company (society) of urology at the patients at intermediate or high risk of second offense (recurrence) after local treatment(processing), has to concern the obturating pit, the internal and external iliac territories. However this type(chap) of cleaning out does not seem to solve all the problems of locoregional stratification. Indeed, several studies concerning the radio-controlled cleaning out highlighted that 10 in 30% of ganglions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

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

  • France
      • Marseille, France, 13354
        • Assistance Publique Hôpitaux de Marseille

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

No

Description

Inclusion Criteria:

  • Subject man, whose age is greater than or equal to 18 years
  • Carrier of cancer intermediate risk non-metastatic prostate or high relapse
  • Subject with an initial balance sheet expansion, regional and general negative by Scanner, abdominopelvic MRI or bone scan,
  • Subject has undergone a medical examination in connection with the study,
  • Topic for which a radical prostatectomy is considered curative purposes,
  • Supported by Subject surgical teams involved in the study,
  • Topic affiliated to a social security scheme,
  • Subject who signed informed consent.

Exclusion Criteria:

  • Subject man, whose age is less than 18 years
  • Subject who have received hormone therapy or radiation therapy for prostate cancer
  • Subject who had surgery for prostate adenoma (transurethral resection or open surgery) because of potential difficulties injection of radioactive tracer in the gland,
  • Subject has a history of pelvic surgery or radiotherapy,
  • Subject with inguinal hernia repair history of laparoscopic,
  • Subject refusing blood transfusions,
  • Subject is not agreeing to participate in this study and did not sign the informed consent.

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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lymphadenectomy
Procedure: standard lymphadenectomy
Procedure: lymphadenectomy radio-isotope method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of sentinel nodes radiolabeled
Time Frame: 54 months
Number of sentinel nodes radiolabeled radiolabeled in the area of standard cleaning
54 months
Number of sentinel nodes radiolabeled
Time Frame: 54 months
Number of sentinel nodes radiolabeled outside the standard cleaning of territory
54 months

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

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.

General Publications

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 (Actual)

January 9, 2013

Primary Completion (Actual)

March 19, 2019

Study Completion (Actual)

April 7, 2023

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 7, 2016

First Posted (Estimate)

April 8, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-07
  • 2012-A-000287-36 (Registry Identifier: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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