NCT00027794已完成2 期
Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study
European Organisation for Research and Treatment of Cancer - EORTC10 个研究点 分布在 3 个国家目标入组 40 人开始时间: 2001年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 10
研究概览
简要总结
RATIONALE: Radical prostatectomy may be an effective treatment for locally advanced prostate cancer.
PURPOSE: Phase II trial to study the effectiveness of radical prostatectomy in treating patients who have locally advanced prostate cancer.
详细描述
OBJECTIVES:
- Determine the success rate of radical prostatectomy in patients with locally advanced adenocarcinoma of the prostate.
- Determine the serious toxic event rate of this surgery in these patients.
- Determine the pN status of patients treated with this surgery.
- Determine the percentage of patients found to have organ-confined tumors (pT2) after undergoing this surgery.
- Determine the 2-year prostate-specific antigen-free survival rate of patients treated with this surgery.
- Determine the surgical morbidity rates of patients treated with this surgery.
OUTLINE: This is a multicenter study.
Patients undergo limited pelvic lymphadenectomy and then radical retropubic prostatectomy.
Patients who are found to have pN-positive disease receive further treatment according to the investigator's discretion. Patients with pN0 disease are followed every 3 months for 1 year and then every 4 months for 1 year.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, 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
- •Unilateral cT3a, cN0, M0
- •Well or moderately differentiated tumor
- •Gleason score no greater than 7 (4 plus 3 or 3 plus 4)
- •Total serum prostate-specific antigen no greater than 20 ng/mL (Hybritech equivalent)
- •PATIENT CHARACTERISTICS:
- •70 and under
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 9 g/dL
- •Bilirubin no greater than 1.5 times normal
- •ALT or AST less than 3 times normal
- •PT and PTT normal
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •No preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
- •No myocardial infarction within the past 6 months
- •No gross abnormalities on chest x-ray
- •No other disease that would preclude surgery
- •No other prior malignancy except adequately treated basal cell skin cancer
- •No other concurrent primary malignancy
- •No psychological, familial, sociological, or geographical condition that would preclude compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No prior hormonal therapy that would affect assessment of clinical T staging, margin positivity, or definitive pT staging
- •Radiotherapy:
- •No prior pelvic radiotherapy that would affect surgical resectability and perioperative morbidity
- •No prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any surgery for benign prostatic hypertrophy, or transurethral resection of prostate) that would preclude prostatectomy
排除标准
- 未提供
研究者
研究点 (10)
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