Clinical trial NCT01442246: Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.
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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Metastases
Keywords: Benefit of
adjuvant
treatment
prostatectomy
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2011-09-28
Enrollment: 700
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility 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 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

Primary outcomes:
measure: 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.
timeFrame: The principal criterion will be evaluated 12 years after the inclusion of the first patient.
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Clinique Victor Pauchet
city: Besancon
country: France
facility: Chu Besancon
city: Bordeaux
country: France
facility: Chu Bordeaux- Hopital Pellegrin
city: Bordeaux
country: France
facility: Institut Bergonie
city: Brest
country: France
facility: Chru de Brest
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: Chu Bocage
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental
city: Lille
country: France
facility: Chru Lille
city: Limoges
country: France
facility: Chu Limoges
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Marseille
country: France
facility: Hopital Nord
city: Montpellier
country: France
facility: Clinique Beausoleil
city: Montpellier
country: France
facility: Hopital Lapeyronie
city: Nancy
country: France
facility: Chu de Nancy
city: Nantes
country: France
facility: Chu Nantes
city: Nice
country: France
facility: Chu Pasteur
city: Nimes
country: France
facility: Chu Caremeau
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Hopital Tenon
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Poitiers
country: France
facility: Chu La Miletrie
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Chu Pontchaillou
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Saint Brieuc
country: France
facility: Centre Hopsitalier Prive - Polyclinique Du Littoral
city: Saint Etienne
country: France
facility: Clinique Mutualiste
city: Strasbourg
country: France
facility: Chu Strasbourg
city: Strasbourg
country: France
facility: Hopitaux Civils de Colmar
city: Suresnes
country: France
facility: Hopital Foch
city: Toulouse
country: France
facility: Chu Rangueil
Study officials:
affiliation: Montsouris Institute, Paris
name: François ROZET, MD
role: STUDY_DIRECTOR
affiliation: Saint-Louis Hospital, Paris, France
name: Stephane Culine, Prof, MD
role: STUDY_CHAIR
References: