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

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Patient With Prostate Cancer

Treatments

Procedure: standard lymphadenectomy

Procedure: lymphadenectomy radio-isotope method

Study type

Interventional

Funder types

Other

Identifiers

NCT02732392

2012-A-000287-36 (Registry Identifier)

2012-07

Details and patient eligibility

About

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.

Enrollment

177 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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.