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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01442246
First received: September 27, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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)

Condition Intervention Phase
Metastases
Drug: Leuprorelin Acetate ((Eligard® )
Other: Reference arm
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • 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. [ Time Frame: The principal criterion will be evaluated 12 years after the inclusion of the first patient. ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: June 2011
Estimated Study Completion Date: January 2023
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adjuvant treatment Drug: Leuprorelin Acetate ((Eligard® )
Leuprorelin Acetate 45mg, one injection every 6 months for 24 months
No Intervention: Surveillance Other: Reference arm
Reference arm is only a surveillance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442246

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

No publications provided

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01442246     History of Changes
Other Study ID Numbers: AFU-GETUG 20/0310
Study First Received: September 27, 2011
Last Updated: September 27, 2011
Health Authority: France: Agence Française de Sécurité Sanitaire des Produits de Santé

Keywords provided by UNICANCER:
Benefit of
adjuvant
treatment
prostatectomy

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 01, 2014