EUCTR2007-000323-17-DE进行中（未招募）不适用
A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation with Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects with a Rising PSA Following Definitive Local Therapy
sanofi-aventis US0 个研究点目标入组 412 人开始时间: 2008年10月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 412
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.Diagnosis of prostate adenocarcinoma pathologically confirmed.
- •2.History of radical prostatectomy (pre-operative radiation therapy to the prostate or pelvis or salvage radiation after radical prostatectomy is allowed).
- •3.Demonstration of biochemical progression of disease based on PSA doubling time. The minimum PSA value for eligibility will be greater than or equal to 1. PSA doubling time over three values must be = 9 months with a minimum of 3 weeks between assessments. PSA doubling time calculation must start at a minimum value of 0.2 (see Section 13.2). Subjects in this group may have no radiographic findings that are suspicious for metastatic disease.
- •4.Serum testosterone = 100 ng/dl.
- •5.Karnofsky performance status (KPS) = 70%.
- •6.Adequate organ function as defined by the following laboratory criteria:
- •WBC = 3500/mm3
- •ANC = 1500/mm3
- •Platelet count = 100,000/mm3
- •Hemoglobin= 10.0 g/dl
- •Total Bilirubin = ULN unless due to Gilbert’s disease
- •Creatinine=1.5 mg/dl or creatinine clearance of = 60 cc/min
- •AST and ALT and Alkaline Phosphatase must be within the range as indicated in the protocol
- •7.Previous hormonal therapy is allowed provided that the total duration of therapy does not exceed 6 months.
- •8.Male subjects must be at least 18 years of age.
- •9.Subjects must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.
- •10.Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- •11.Subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
- •2.Uncontrolled serious active infection.
- •3.Anticipated duration of life of less than 2 years
- •4.Less than 5-year history of successful treatment for other cancers or concurrent active nonprostate cancer other than nonmelanoma skin tumor.
- •5.Peripheral neuropathy =Grade 2.
- •6.History of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80, leuprolide, or bicalutamide.
- •7.Prior chemotherapy within the past 10 years (except non-taxane based chemotherapy for treatment of other cancers); concurrent treatment on another clinical trial or with any other cancer therapy including chemotherapy, immunotherapy, radiotherapy (except pre-operative radiation or salvage radiation therapy after prostatectomy), chemoembolization therapy, cryotherapy.
- •8.Other severe acute or chronic medical conditions including psychiatric disease(s), or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject’s safety, delay or prohibit protocol participation, or interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
- •9.Radiographic findings suspicious for metastatic disease in the treating physician’s clinical judgment. Patients who had radiographically suspicious pelvic lymph nodes prior to radical prostatectomy, but who, at the time of registration to the trial do not have suspicious adenopathy (for example, either because those nodes were resected or were irradiated post-operatively) are eligible for the protocol. Patients are eligible even if they had tumor-containing pelvic adenopathy at the time of surgery as long as at the time of registration they do not have radiographically evident nodal disease in the clinician's opinion.
- •10.Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- •11.Subject unlikely to comply with protocol or research tests, eg, uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- •12. Subject who participated in any therapeutic clinical study/ received investigational product within 30 days of screening.
研究者
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