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

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.

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Metastases
• Intervention / Treatment: Drug: Leuprorelin Acetate

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • Clinique Victor Pauchet
  • Besancon, France, 25030
    • CHU Besançon
  • Bordeaux, France, 33076
    • Institut Bergonie
  • Bordeaux, France, 33000
    • Chu Bordeaux- Hopital Pellegrin
  • Brest, France, 29069
    • CHRU de Brest
  • Creteil, France, 94010
    • Hopital Henri Mondor
  • Dijon, France, 21079
    • CHU Bocage
  • La Roche Sur Yon, France, 85925
    • Centre Hospitalier Departemental
  • Lille, France, 59037
    • CHRU Lille
  • Limoges, France, 87042
    • CHU Limoges
  • Lyon, France, 69437
    • Hôpital Edouard Herriot
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Marseille, France, 13015
    • Hopital Nord
  • Montpellier, France, 34295
    • Hopital Lapeyronie
  • Montpellier, France, 34070
    • Clinique Beausoleil
  • Nancy, France, 54500
    • CHU de Nancy
  • Nantes, France, 44093
    • CHU Nantes
  • Nice, France, 06002
    • CHU Pasteur
  • Nimes, France, 30029
    • CHU Caremeau
  • Paris, France, 75010
    • Hopital Saint Louis
  • Paris, France, 75651
    • Hopital Pitie Salpetriere
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Paris, France, 75020
    • Hopital Tenon
  • Paris, France, 75014
    • Hopital Cochin
  • Paris, France, 75015
    • HEGP
  • Poitiers, France, 86000
    • Chu La Miletrie
  • Reims, France, 51056
    • Institut Jean Godinot
  • Rennes, France, 35033
    • Chu Pontchaillou
  • Rouen, France, 76031
    • Hopital Charles Nicolle
  • Saint Brieuc, France, 22000
    • Centre Hopsitalier Prive - Polyclinique Du Littoral
  • Saint Etienne, France, 42013
    • Clinique Mutualiste
  • Strasbourg, France, 67090
    • CHU Strasbourg
  • Strasbourg, France, 68024
    • Hôpitaux Civils de Colmar
  • Suresnes, France, 92150
    • Hopital Foch
  • Toulouse, France, 31059
    • CHU Rangueil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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:

1. Previous treatments for prostatic adenocarcinoma (HT or orchiectomy 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adjuvant treatment; Leuproreline acetate	Drug: Leuprorelin Acetate; Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months; Other Names: Eligard®
No Intervention: Surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	The principal criterion will be evaluated 12 years after the inclusion of the first patient.

Collaborators and Investigators

• Sponsor: UNICANCER
• Collaborators: Astellas Pharma Inc
• Investigators: Study Director: François ROZET, MD, Montsouris Institute, Paris; Study Chair: Stephane Culine, Prof, MD, Saint-Louis Hospital, Paris, France

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 27, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimated): September 28, 2011

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: treatment; adjuvant; prostatectomy; Benefit of
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide
• Other Study ID Numbers: AFU-GETUG 20 - UC-0160/1003; 2010-022037-29 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No