NCT01819285已完成3 期
Phase III Comparison of Early vs Delayed Endocrine Manipulation (Orchiectomy or LHRH Agonist Therapy) in Previously Untreated Patients With Nonmetastatic Asymptomatic Carcinoma of the Prostate
European Organisation for Research and Treatment of Cancer - EORTC0 个研究点目标入组 985 人开始时间: 1990年2月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 985
- 主要终点
- Overall survival
研究概览
简要总结
Objectives
I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy).
II. Compare the overall survival of these two groups of patients.
III. Compare the time to first evidence of distant progression (N4 or M1) of these two treatment groups.
IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these parameters following endocrine therapy.
V. Study the prognosis of various sub-groups of patients stratified according to performance status, local tumor extent, nodal status, and choice of endocrine treatment.
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate T0-4 N0-2 M0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy).
- •All T stages are acceptable (UICC 1982). The stage is determined by rectal palpation.
- •Patients with regional lymph node metastases smaller than 5 cm (N0-2), determined either by CT or ultrasonography, preferable with cytologic confirmation.
- •Life expectancy of at least six months.
- •WHO performance status score 0-
- •Informed consent. Patients must be prepared to undergo an orchiectomy or continuous treatment with a depot LHRH analogue.
- •Continuous follow-up until death if possible.
排除标准
- •Other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin.
- •Prostate cancer known for longer than one month before entering the study.
- •Pain caused by the prostate cancer or its metastases.
- •Any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) Note: TUR-P for voiding disturbances is allowed at any time and is not an exclusion criterion.
- •Patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins).
- •Patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, N3-4).
- •Patients with evidence of distant metastases (bone, lung, liver).
- •Age over 80 years. Performance status WHO score 2, 3 and 4 (any reason).
- •Patient who refuses orchiectomy or longterm subcutaneous implants of LHRH analogue in two monthly intervals.
- •Expected difficulties with follow-up for any reason.
结局指标
主要结局
Overall survival
时间窗: 13 years from first patient in
次要结局
- Prognostic importance of pretreatment laboratory data(13 years from first patient in)
- Overall symptom free survival time(13 years from first patient in)
- Time until first evidence of distant progression(13 years from first patient in)
- Prognosis of particular sub-groups(13 years from first patient in)
研究者
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