NCT01442246进行中（未招募）3 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 700
- 试验地点
- 35
- 主要终点
- 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.
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients who have received the information leaflet and signed the consent form
- •≥18 years of age with a life expectancy of at least 10 years
- •Performance Status (ECOG) ≤2
- •Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion
- •Histologically confirmed prostatic adenocarcinoma
- •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
- •Postoperative PSA <0.1 ng/mL (dosage perform within 2 months after surgery)
- •Neutrophils ≥1500/mm³, platelets ≥100000/mm³
- •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)
- •Patients affiliated to a social security scheme
排除标准
- •Previous treatments for prostatic adenocarcinoma (HT or orchiectomy or CT)
- •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
- •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
- •Incompatible concomitant treatment(s)
- •Hypersensitivity to other GnRH agonists and/or any of the excipients of Eligard®
- •Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial
- •Persons deprived of their freedom or under supervision (including guardianship),
- •Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days
研究组 & 干预措施
Adjuvant treatment
Experimental
Leuproreline acetate
干预措施: Leuprorelin Acetate (Drug)
结局指标
主要结局
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.
时间窗: The principal criterion will be evaluated 12 years after the inclusion of the first patient.
次要结局
未报告次要终点
研究者
研究点 (35)
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