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

Primary Purpose

Patient With Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
standard lymphadenectomy
lymphadenectomy radio-isotope method
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patient With Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lymphadenectomy

Arm Description

Outcomes

Primary Outcome Measures

Number of sentinel nodes radiolabeled
Number of sentinel nodes radiolabeled radiolabeled in the area of standard cleaning
Number of sentinel nodes radiolabeled
Number of sentinel nodes radiolabeled outside the standard cleaning of territory

Secondary Outcome Measures

Full Information

First Posted
March 30, 2016
Last Updated
May 23, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02732392
Brief Title
Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer
Acronym
SENTINELLE
Official Title
Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 9, 2013 (Actual)
Primary Completion Date
March 19, 2019 (Actual)
Study Completion Date
April 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient With Prostate Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lymphadenectomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
standard lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
lymphadenectomy radio-isotope method
Primary Outcome Measure Information:
Title
Number of sentinel nodes radiolabeled
Description
Number of sentinel nodes radiolabeled radiolabeled in the area of standard cleaning
Time Frame
54 months
Title
Number of sentinel nodes radiolabeled
Description
Number of sentinel nodes radiolabeled outside the standard cleaning of territory
Time Frame
54 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
36331157
Citation
Lannes F, Baboudjian M, Ruffion A, Rouy M, Giammarile F, Rousseau T, Kraeber-Bodere F, Rousseau C, Rusu D, Colombie M, Brenot-Rossi I, Rossi D, Mottet N, Bastide C. Radioisotope-guided Lymphadenectomy for Pelvic Lymph Node Staging in Patients With Intermediate- and High-risk Prostate Cancer (The Prospective SENTINELLE Study). J Urol. 2023 Feb;209(2):364-373. doi: 10.1097/JU.0000000000003043. Epub 2022 Nov 4.
Results Reference
derived

Learn more about this trial

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

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