Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.
NCT ID: NCT01442246
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
700 participants
INTERVENTIONAL
2011-07-31
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
SECONDARY OBJECTIVE(S):
* PSA evolution
* Evaluation of testosterone level
* Specific survival
* Overall survival
* Tolerance
* Quality of life (QLQ-C30 questionnaires)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
NCT00378690
An Observational Study Looking at How Well the Drug Eligard Works and How Well it is Tolerated by the Body of Patients With Advanced Prostate Carcinoma in the Russian Federation
NCT02128334
Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy
NCT00283062
A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer
NCT00220194
Study to Evaluate the Safety and Efficacy of Switching From Zoladex® Monthly or Quarterly, to Eligard® Semiannual.
NCT05304169
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adjuvant treatment
Leuproreline acetate
Leuprorelin Acetate
Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months
Surveillance
Surveillance
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Leuprorelin Acetate
Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. ≥18 years of age with a life expectancy of at least 10 years
3. Performance Status (ECOG) ≤2
4. Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion
5. Histologically confirmed prostatic adenocarcinoma
6. Patients R0, N0 or Nx or N+ (≤ 2 nodes among nodes removed), M0 and with at least one of the following criteria:
* postoperative Gleason score \>7
* postoperative Gleason score =7 with the presence of high-grade Gleason patterns
* pT3b patients
7. Postoperative PSA \<0.1 ng/mL (dosage perform within 2 months after surgery)
8. Neutrophils ≥1500/mm³, platelets ≥100000/mm³
9. Bilirubin ≤ upper normal limit (this will not apply to subjects with Gilbert's syndrome, persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology); ASAT and ALAT ≤1.5 times upper normal limit; Creatinine \<140 µmol/l (or clearance \>60 mL/min)
10. Patients affiliated to a social security scheme
Exclusion Criteria
2. Presence of metastases:
* positive bone scintigraphy, including Patients with medullary compression and/or
* abdominal-pelvic CT scan or MRI showing lymph node and/or visceral involvement
3. History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission
4. Incompatible concomitant treatment(s)
5. Hypersensitivity to other GnRH agonists and/or any of the excipients of Eligard®
6. Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial
7. Persons deprived of their freedom or under supervision (including guardianship),
8. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astellas Pharma Inc
INDUSTRY
UNICANCER
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
François ROZET, MD
Role: STUDY_DIRECTOR
Montsouris Institute, Paris
Stephane Culine, Prof, MD
Role: STUDY_CHAIR
Saint-Louis Hospital, Paris, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinique Victor Pauchet
Amiens, , France
Chu Besancon
Besançon, , France
Chu Bordeaux- Hopital Pellegrin
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Chru de Brest
Brest, , France
Hopital Henri Mondor
Créteil, , France
Chu Bocage
Dijon, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Chru Lille
Lille, , France
Chu Limoges
Limoges, , France
Hopital Edouard Herriot
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Hopital Nord
Marseille, , France
Clinique Beausoleil
Montpellier, , France
Hopital Lapeyronie
Montpellier, , France
Chu de Nancy
Nancy, , France
Chu Nantes
Nantes, , France
Chu Pasteur
Nice, , France
Chu Caremeau
Nîmes, , France
Hopital Saint Louis
Paris, , France
Hopital Cochin
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
HEGP
Paris, , France
Hopital Tenon
Paris, , France
Hopital Pitie Salpetriere
Paris, , France
Chu La Miletrie
Poitiers, , France
Institut Jean Godinot
Reims, , France
Chu Pontchaillou
Rennes, , France
Hopital Charles Nicolle
Rouen, , France
Centre Hopsitalier Prive - Polyclinique Du Littoral
Saint-Brieuc, , France
Clinique Mutualiste
Saint-Etienne, , France
Chu Strasbourg
Strasbourg, , France
Hopitaux Civils de Colmar
Strasbourg, , France
Hopital Foch
Suresnes, , France
Chu Rangueil
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-022037-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AFU-GETUG 20 - UC-0160/1003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.