A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 16
- 主要终点
- quality of life
研究概览
简要总结
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining hormone therapy with internal radiation may be effective in treating locally recurrent prostate cancer.
PURPOSE: Phase II trial to study the effectiveness of hormone therapy followed by internal radiation in treating patients who have locally recurrent prostate cancer following external-beam radiation therapy.
详细描述
OBJECTIVES:
- Determine the nature, intensity, and time course of health-related quality of life changes in patients with locally recurrent prostate adenocarcinoma treated with androgen suppression and transperineal ultrasound-guided brachytherapy after external beam radiotherapy.
- Determine the morbidity of patients treated with this regimen.
- Determine the overall survival, disease-free survival, and disease-specific survival of patients treated with this regimen.
- Determine the clinical patterns of tumor recurrence (i.e., time to local tumor progression or distant failure) and time to biochemical failure of patients treated with this regimen.
- Determine the post-brachytherapy dosimetric coverage of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive androgen suppression comprising goserelin subcutaneously (as either 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection) OR leuprolide intramuscularly (as 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection or 1 four-month depot injection) AND oral flutamide 3 times daily for 112 days OR oral bicalutamide once daily for 112 days.
Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled to 2 different cohorts of brachytherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（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
结局指标
主要结局
quality of life
时间窗: Up to 10 years
次要结局
- Morbidity(Up to 10 years)
- Disease specific survival(Up to 10 years)
- Disease free survival(Up to 10 years)
- tumor recurrence(Up to 10 years)