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Benefit Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.

Information source: UNICANCER
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastases

Intervention: Leuprorelin Acetate ((Eligard® ) (Drug); Reference arm (Other)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: UNICANCER

Official(s) and/or principal investigator(s):
François ROZET, MD, Study Director, Affiliation: Montsouris Institute, Paris
Stephane Culine, Prof, MD, Study Chair, Affiliation: Saint-Louis Hospital, Paris, France

Summary

PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard 45 mg) for 24 months after radical prostatectomy in patients with high risk of recurrence. SECONDARY OBJECTIVE(S):

- PSA evolution

- Evaluation of testosterone level

- Specific survival

- Overall survival

- Tolerance

- Quality of life (QLQ-C30 questionnaires)

Clinical Details

Official title: Phase III Randomised Trial to Evaluate the Benefit of Adjuvant Hormonal Treatment With Leuprorelin Acetate (Eligard 45 mg) for 24 Months After Radical Prostatectomy in Patients With High Risk of Recurrence.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The principal criterion is the evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria: 1. Patients who have received the information leaflet and signed the consent form 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 with postoperative Gleason score > 7, or ≥ 7 with the presence of high-grade Gleason patterns (5) and R0, N0 or Nx , M0 or Patients pT3b, R0, N0 or Nx , M0 whatever the Gleason score 7. Postoperative PSA < 0. 1 ng/mL (dosage perform within 2 months after surgery) 8. Neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3 9. Bilirubin ≤ upper normal limit (this will not apply to subjects with Gilbert's syndrome, persistent or recurrent hyperbilirubinemia that is predominantly uncongugated 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 > 60mL/min) 10. Patients affiliated to a social security scheme Exclusion Criteria: 1. Previous treatments for prostatic adenocarcinoma (HT or orchyectomy or CT) 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.

Locations and Contacts

Clinique Victor Pauchet, Amiens 80000, France

Chu Besancon, Besancon 25030, France

Chu Bordeaux- Hopital Pellegrin, Bordeaux 33000, France

Institut Bergonie, Bordeaux 33076, France

Chru de Brest, Brest 29069, France

Hopital Henri Mondor, Creteil 94010, France

Chu Bocage, Dijon 21079, France

Centre Hospitalier Departemental, La Roche Sur Yon 85925, France

Chru Lille, Lille 59037, France

Chu Limoges, Limoges 87042, France

Hopital Edouard Herriot, Lyon 69437, France

Hopital Nord, Marseille 13015, France

Institut Paoli Calmettes, Marseille 13009, France

Clinique Beausoleil, Montpellier 34070, France

Hopital Lapeyronie, Montpellier 34295, France

Chu de Nancy, Nancy 54500, France

Chu Nantes, Nantes 44093, France

Chu Pasteur, Nice 06002, France

Chu Caremeau, Nimes 30029, France

HEGP, Paris 75015, France

Hopital Cochin, Paris 75014, France

Hopital Pitie Salpetriere, Paris 75651, France

Hopital Saint Louis, Paris 75010, France

Hopital Tenon, Paris 75020, France

Institut Mutualiste Montsouris, Paris 75014, France

Chu La Miletrie, Poitiers 86000, France

Institut Jean Godinot, Reims 51056, France

Chu Pontchaillou, Rennes 35033, France

Hopital Charles Nicolle, Rouen 76031, France

Centre Hopsitalier Prive - Polyclinique Du Littoral, Saint Brieuc 22000, France

Clinique Mutualiste, Saint Etienne 42013, France

Chu Strasbourg, Strasbourg 67090, France

Hopitaux Civils de Colmar, Strasbourg 68024, France

Hopital Foch, Suresnes 92150, France

Chu Rangueil, Toulouse 31059, France

Additional Information

Starting date: June 2011
Last updated: September 27, 2011

Page last updated: August 23, 2015

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