NCT02732392

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 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

Study Start

First participant enrolled

January 9, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2019

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2023

Completed
Last Updated

May 24, 2023

Status Verified

April 1, 2023

Enrollment Period

6.2 years

First QC Date

March 30, 2016

Last Update Submit

May 23, 2023

Conditions

Patient With Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Number of sentinel nodes radiolabeled

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

    54 months

  • Number of sentinel nodes radiolabeled

    Number of sentinel nodes radiolabeled outside the standard cleaning of territory

    54 months

Study Arms (1)

lymphadenectomy

EXPERIMENTAL
Procedure: standard lymphadenectomyProcedure: lymphadenectomy radio-isotope method

Interventions

standard lymphadenectomyPROCEDURE
lymphadenectomy
lymphadenectomy radio-isotope methodPROCEDURE
lymphadenectomy

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • 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.

    PMID: 36331157DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 8, 2016

Study Start

January 9, 2013

Primary Completion

March 19, 2019

Study Completion

April 7, 2023

Last Updated

May 24, 2023

Record last verified: 2023-04

Locations

FR(1)