A Phase II Study Using High Dose Three Dimensional Conformal Radiation Therapy in Intermediate Prognostic Risk Patients With Adenocarcinoma of the Prostate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy.
PURPOSE: This phase II trial is studying how well radiation therapy that has been planned with a computer works in treating patients with prostate cancer.
详细描述
OBJECTIVES:
- Establish the efficacy of high-dose three-dimensional conformal radiotherapy in patients with intermediate prognostic risk adenocarcinoma of the prostate.
- Determine the PSA relapse-free survival rate of this patient population.
OUTLINE: Patients receive high-dose three-dimensional conformal radiotherapy 4-5 days per week for at least 9 weeks.
Patients are evaluated at least weekly during radiotherapy and at 2 and 4 months after treatment completion. Thereafter, patients are followed every 6 months for a total of 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven intermediate prognostic risk (T1-T2) adenocarcinoma of the prostate
- •Previously untreated (except for hormonal therapy)
- •PSA levels greater than 10 ng/mL and Gleason scores no greater than 6 OR
- •PSA levels no greater than 10 ng/mL and Gleason scores at least 7
- •Patients requiring volume reduction of prostate prior to radiotherapy continue to be treated at least 3 months on neoadjuvant hormonal therapy prior to radiation
- •No evidence of distant metastases
- •No regional lymph node involvement
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No major medical illness
- •No psychosis
- •No metallic pelvic prosthesis
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •Prior neoadjuvant antiandrogen therapy allowed
- •Radiotherapy:
- •No prior radiotherapy
- •No prior pelvic irradiation
- •No prior radical surgery for carcinoma of the prostate
排除标准
- 未提供