Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 26
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.
详细描述
OBJECTIVES:
- Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk localized prostate cancer.
- Determine the safety of EBRT+BT in these patients.
- Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder injury, in these patients.
OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks.
Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Androgen suppression + EBRT + Brachytherapy
Androgen suppression with external beam radiation therapy followed by brachytherapy boost
干预措施: LHRH agonist (Drug)
Androgen suppression + EBRT + Brachytherapy
Androgen suppression with external beam radiation therapy followed by brachytherapy boost
干预措施: antiandrogen (Drug)
Androgen suppression + EBRT + Brachytherapy
Androgen suppression with external beam radiation therapy followed by brachytherapy boost
干预措施: radiation therapy (Radiation)
Androgen suppression + EBRT + Brachytherapy
Androgen suppression with external beam radiation therapy followed by brachytherapy boost
干预措施: Brachytherapy boost (Radiation)
结局指标
主要结局
Toxicity
时间窗: q 3 mon for 2 yrs post tx initiation
次要结局
- Survival(6 years)
- Time to PSA failure(6 years)