NCT00376792Unknown3 期
An Open Randomized Phase III Trial of Six Cycles of Docetaxel Versus Surveillance After Radical Prostatectomy in High Grade Prostate Cancer Patients With Margin Positive T2 or T3 Tumours
Scandinavian Prostate Cancer Group16 个研究点 分布在 5 个国家目标入组 396 人开始时间: 2005年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 396
- 试验地点
- 16
- 主要终点
- Prostate-specific antigen (PSA) progression
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving docetaxel after surgery is more effective than observation in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying docetaxel to see how well it works compared with observation in treating patients who have undergone radical prostatectomy for prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare time to prostate-specific antigen (PSA) progression in patients with margin-positive tumors after undergoing radical prostatectomy for high-grade prostate cancer treated with docetaxel versus observation.
Secondary
- Compare PSA doubling time in patients treated with these regimens.
- Compare quality of life of these patients.
- Compare overall and metastasis-free survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate meeting one of the following criteria after undergoing radical prostatectomy:
- •pT2 with Gleason score 4+3 or 8-10 and positive margins in the radical prostatectomy specimen
- •Any pT3a tumor with Gleason score ≥ 4+3
- •pT3b tumor with Gleason score ≥ 7
- •Negative lymph nodes at histological examination (N0)
- •Patients with a preoperative prostate-specific antigen (PSA) ≥ 10.0 ng/mL should have undergone a lymph node dissection
- •Postoperative PSA must be < 0.5 ng/mL
- •Considered at high risk for recurrent disease
- •No metastatic (M0) disease
- •Negative bone scan
- •PATIENT CHARACTERISTICS:
- •WHO/ECOG performance status 0-1
- •Hemoglobin ≥ 11.0 g/dL
- •Neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 150,000/mm³
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin normal
- •AST and ALT ≤ 1.5 times ULN
- •Alkaline phosphatase < 1.5 times ULN
- •No active untreated infectious disease (e.g., tuberculosis or methicillin-resistant Staphylococcus aureus)
- •No active gastric ulcer
- •No known hypersensitivity to polysorbate 80
- •No symptomatic peripheral neuropathy ≥ grade 2
- •No myocardial infarction within the past 6 months
- •No other unstable cardiovascular disease within the past 6 months
- •No other serious illness or medical condition
- •No altered psychological or physical state that would preclude study compliance
- •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior hormonal therapy (e.g., luteinizing hormone-releasing hormone analogues and/or antiandrogens) affecting prostate cancer cells
- •No prior radiotherapy to the pelvis
- •No prior chemotherapy
- •More than 6 months since prior systemic corticosteroids
- •No other concurrent anticancer therapy or investigational drugs
排除标准
- 未提供
结局指标
主要结局
Prostate-specific antigen (PSA) progression
次要结局
- PSA doubling time
- Quality of Life
- Metastasis-free survival
- Overall survival
研究者
研究点 (16)
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