Clinical trial NCT02732392: Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer
Official title: Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient With Prostate Cancer
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 177
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of sentinel nodes radiolabeled
timeFrame: 54 months
measure: Number of sentinel nodes radiolabeled
timeFrame: 54 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References:
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.