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. - AFU-GETUG 20

ICANCER0 个研究点目标入组 700 人开始时间: 2013年12月16日最近更新: 2015年12月7日

适应症

试验速览

暂无简介。

•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
•7. Postoperative PSA < 0.1 ng/mL (dosage perform within 2 months after surgery) whatever the Gleason score
•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1. Previous treatments for prostatic adenocarcinoma (HT or orchyectomy or CT)
•2. Presence of metastases:
•- positive bone scintigraphy including Patients with medullary compression
•- 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.

发起方

ICANCER