A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 307
- 试验地点
- 1
- 主要终点
- Freedom from biochemical and/or disease failure rates
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer.
详细描述
OBJECTIVES:
- Compare the efficacy of conventional intensity-modulated radiotherapy (IMRT) vs hypofractionated IMRT, in terms of freedom from biochemical failure in men with intermediate- to high-risk prostate cancer.
- Compare the local control, freedom from distant metastasis, and overall survival of patients treated with these regimens.
- Determine local failure, using biopsy of the prostate, when objective tests (prostate-specific antigen, ultrasound, and digital rectal exam) suggest relapse in these patients.
- Compare the extent of disease eradication using biopsy of the prostate at 2 years after therapy in these patients.
- Compare the quality of life of patients treated with these regimens.
- Determine the impact of these regimens on patient preferences and utilities.
OUTLINE: This is a randomized study. Patients are stratified according to pretreatment prostate-specific antigen (no greater than 10 ng/mL vs greater than 10 to 20 ng/mL vs greater than 20 ng/mL), Gleason score (5-7 vs 8-10), and risk status (high risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) 5 days a week for 7.5 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo hypofractionated IMRT 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
Patients with high-risk disease also undergo androgen deprivation therapy for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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
- •Clinical stage T1b-T3c disease
- •No clinical or radiographic evidence of metastasis
- •Prostate-specific antigen (PSA) less than 80 ng/mL
- •Gleason score at least 5
- •One of the following criteria must be met:
- •PSA greater than 10 ng/mL
- •Gleason score greater than 6
- •T2b or greater palpable disease
- •Three or more biopsy cores involved with a Gleason score of at least 5
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •No other medical condition that would preclude study participation
- •No other active malignancy within the past 5 years except nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic leukemia)
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •No more than 4 months of prior androgen deprivation therapy
- •Neoadjuvant and adjuvant androgen deprivation therapy is allowed for high-risk disease only
- •Radiotherapy
- •No prior pelvic radiotherapy
- •No prior or planned radical prostate surgery
排除标准
- 未提供
研究组 & 干预措施
CIMRT
76 Gy in 38 fractions
干预措施: radiation therapy (Radiation)
HIMRT
70.2 Gy in 26 fractions
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Freedom from biochemical and/or disease failure rates
时间窗: weekly during treatment, at 3 months, 6 months or 2 years then yearly
次要结局
未报告次要终点