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

Unicancer

Status and phase: Active, not recruiting; Phase 3

Conditions: Metastases

Treatments: Drug: Leuprorelin Acetate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01442246

2010-022037-29 (EudraCT Number)

AFU-GETUG 20 - UC-0160/1003

Details and patient eligibility

About

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)

Enrollment: 700 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Adjuvant treatment

Experimental group

Description:

Leuproreline acetate

Treatment:

Drug: Leuprorelin Acetate

Surveillance

No Intervention group

Description:

Surveillance