Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with prostate cancer.
详细描述
OBJECTIVES:
- Assess the disease free survival of patients with localized adenocarcinoma of the prostate cancer.
- Evaluate the toxic effects of three dimensional conformal external beam radiotherapy and androgen deprivation in these patients.
OUTLINE: Patients are stratified according to PSA values and Gleason scores (class II versus class III/IV).
Patients receive intramuscular leuprolide acetate every 3 months, and oral flutamide tid.
Patients are evaluated on a monthly basis for response. Patients with unchanged or undetectable prostate specific antigen levels are considered to have reached maximal hormonal response and three dimensional conformal external beam radiotherapy is instituted. In addition, patients with disease progression are considered to have reached maximal response, and three dimensional conformal external beam radiotherapy is instituted. Radiotherapy must be administered within 6 months after initiation of leuprolide and flutamide therapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven localized adenocarcinoma of the prostate
- •Prostate specific antigen (PSA) greater than 4 or Gleason score at least 8 if PSA is no greater than 4
- •CT, MRI, or pelvic lymphadenectomy negative for metastases, if PSA is no greater than 50
- •Negative pelvic lymphadenectomy, if PSA is greater than 50
- •Bone scan negative for metastases or PSA no greater than 20
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance Status:
- •Not specified
- •Life Expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm3
- •Platelet count at least 70,000/mm3
- •Hemoglobin at least 10 g/dL
- •Patients on anticoagulant therapy must have a baseline PT test
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •ALT or AST less than 1.5 times ULN
- •Alkaline phosphatase less than 1.5 times ULN
- •Creatinine less than 1.5 times ULN
- •Cardiovascular:
- •No history of collagen vascular disease
- •No acute infection requiring antibiotics
- •No history of hypersensitivity to flutamide
- •No history of hypersensitivity to leuprolide acetate
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供