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OpenTrials
Completed

NCT Number: NCT02732392

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

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.

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Key information

Conditions

Patient With Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standard lymphadenectomy

Procedure

lymphadenectomy radio-isotope method

Procedure

Primary outcomes

  1. Number of sentinel nodes radiolabeled

    Time frame: 54 months

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

  2. Number of sentinel nodes radiolabeled

    Time frame: 54 months

    Number of sentinel nodes radiolabeled outside the standard cleaning of territory

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: SENTINELLE

Important dates

Study start
2013
Primary completion
2019
Study completion
2023
First posted
Apr 8, 2016
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.