A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Participants With Genitourinary Acute Toxicity
研究概览
简要总结
The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.
详细描述
This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.
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
- 40 Years 至 82 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days of study enrollment
- •History/physical examination with digital rectal examination of the prostate within 8 weeks prior to study enrollment
- •Gleason score less than or equal to 7
- •Clinical Stage T1-T2c
- •less than or = 15 ng/ml prior to start of therapy if Gleason < or = 6 or
- •less than or = 10 ng/ml prior to start of therapy if Gleason = 7
- •Zubrod Performance Status 0-1
- •Age > 40
排除标准
- •Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (Carcinoma in situ of the bladder or oral cavity is permissible)
- •Evidence of distant metastases
- •Regional lymph node involvement
- •Significant urinary obstruction
- •Estimated prostate gland > 100 grams
- •Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- •Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- •Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy
- •Previous or concurrent cytotoxic chemotherapy for prostate cancer
- •Prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
- •Severe, active comorbidity
结局指标
主要结局
Number of Participants With Genitourinary Acute Toxicity
时间窗: </= 90 days post radiation treatment, a total of 90 days
Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment
Number of Participants With Gastrointestinal Late Toxicity
时间窗: >90 days from the end of treatment, up to 3 years
Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring \> 90 days from the end of radiation treatment
Number of Participants With Genitourinary Late Toxicity
时间窗: >90 days from the end of treatment, up to 3 years
Genitourinary Late Toxicity is defined as Grade 3 or higher occurring \>90 days from the end of radiation treatment
Number of Participants With Gastrointestinal Acute Toxicity
时间窗: </= 90 days post radiation treatment, a total of 90 days
Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment
次要结局
- Disease Free Survival(5 yrs)
- Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form(3 years post-treatment)