Patient With Prostate CancerSENTINELLENCT02732392
Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer
A study testing standard lymphadenectomy and lymphadenectomy radio-isotope method in people with Patient With Prostate Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Patient With Prostate Cancer
- What is being tested?
- standard lymphadenectomy and lymphadenectomy radio-isotope method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2013to 7 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- standard lymphadenectomy, lymphadenectomy radio-isotope method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard lymphadenectomyProcedure or surgery
lymphadenectomy radio-isotope methodProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| lymphadenectomy | Experimental | Not described Receives: Procedure: standard lymphadenectomy; Procedure: lymphadenectomy radio-isotope method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sentinel nodes radiolabeled
Number of sentinel nodes radiolabeled radiolabeled in the area of standard cleaning
Measured: 54 months
Number of sentinel nodes radiolabeled
Number of sentinel nodes radiolabeled outside the standard cleaning of territory
Measured: 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study start9 Jan 2013
- Primary completion19 Mar 2019
- Study completion7 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient With Prostate CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732392
- Sponsor's protocol ID
- 2012-07
- Other IDs
- 2012-A-000287-36
- Acronym
- SENTINELLE
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2016
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36331157
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT02732392
- Acronym / sponsor ID
- SENTINELLE / 2012-07
- Conditions
- Patient With Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 9 Jan 2013 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lymphadenectomy | Experimental | Procedure: standard lymphadenectomy, Procedure: lymphadenectomy radio-isotope method |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard lymphadenectomy | Procedure or surgery | lymphadenectomy |
| lymphadenectomy radio-isotope method | Procedure or surgery | lymphadenectomy |
Primary outcome
Number of sentinel nodes radiolabeled
Time frame: 54 months
Number of sentinel nodes radiolabeled radiolabeled in the area of standard cleaning
Number of sentinel nodes radiolabeled
Time frame: 54 months
Number of sentinel nodes radiolabeled outside the standard cleaning of territory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 36331157Lannes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard lymphadenectomy and lymphadenectomy radio-isotope method in people with Patient With Prostate Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sentinel nodes radiolabeled (time frame: 54 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02732392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.