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

NCT ID: NCT02732392

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-09
• Study Completion Date: 2023-04-07

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.

Conditions

Patient With Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

lymphadenectomy

Group Type: EXPERIMENTAL

standard lymphadenectomy

Intervention Type: PROCEDURE

lymphadenectomy radio-isotope method

Intervention Type: PROCEDURE

Interventions

standard lymphadenectomy

Intervention Type: PROCEDURE

lymphadenectomy radio-isotope method

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 36331157 (View on PubMed)

Other Identifiers

2012-A-000287-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-07

Identifier Type: -

Identifier Source: org_study_id