Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Survival rates
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Using scintigraphy to plan specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the side effects and best way to give intensity-modulated radiation therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV prostate cancer.
详细描述
OBJECTIVES:
- To assess the feasibility of radioimmunoguided intensity-modulated radiotherapy (IMRT) for stage I-IV prostate cancer.
- To determine the toxicity and tolerance of this regimen in these patients.
- To determine the tumor response based on physical examination and serial measurements of the serum prostate-specific antigen (PSA) levels in these patients.
- To determine the outcome of patients treated on this study with radioimmunoguided IMRT compared to 2 control groups of patients treated at Mayo Scottsdale Clinic (MSC).
OUTLINE: Patients undergo radioimmunoguided intensity-modulated radiotherapy once daily, 5 days a week for 8½ weeks. Beginning the last week of radiotherapy, some patients receive leuprolide acetate intramuscularly every 3-4 months or goserelin subcutaneously every 3 months for 6 months, 12 months, or until disease progression.
After completion of study treatment, patients are followed every 3-4 months for 1 year, every 6 months for 4 years and annually thereafter
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Pathologically confirmed prostate cancer
- •Stage I-IV disease (T1-4, N0-1, M0)
- •No evidence of distant metastases (M0) on physical examination or bone scan
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Hemoglobin ≥ 10.0 g/dL
- •WBC ≥ 3,000/mcL
- •Platelet count ≥ 90,000/mm
- •AST < 2 times the upper limit of normal
- •No allergy to leuprolide acetate or goserelin
- •PRIOR CONCURRENT THERAPY:
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Survival rates
Toxicity
Freedom from biochemical relapse rates
Local control rates
Distant failure rates
Biochemical freedom from failure rates
Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance
次要结局
- Obstructive urinary symptoms
- Sexual health as assessed by inventory questionnaire