A Prospective Protocol of Stereotactic Body Irradiation With Concurrent Intraprostatic Lesion Boost Utilizing Intensity Modulated Radiotherapy for Patients With Low- and Intermediate-Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Biochemical disease-free survival
研究概览
简要总结
The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT) with simultaneous boost (higher radiation dose) to areas within the prostate with more prominent cancerous growth (intraprostatic lesions) utilizing intensity modulated radiotherapy (IMRT) planning techniques is a safe and effective treatment in patients with low- and intermediate-risk localized prostate cancer.
详细描述
Standard external beam radiation therapy (EBRT) for low- to intermediate-risk prostate cancer involves several weeks of daily treatment sessions. Stereotactic body radiation therapy (SBRT) is a newer form of EBRT that gives fewer treatments but higher doses of radiation per treatment. In many patients there are certain areas within the prostate with more prominent cancerous growth (intraprostatic lesions), which may require higher doses of radiation (boost) to treat effectively. This study will treat the prostate with simultaneous boost(s) to intraprostatic lesion(s) in 5 treatments over 10-14 days.
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
- •Histologically proven diagnosis of prostate adenocarcinoma within one year
- •Gleason Score 2-7
- •Clinical T-stage T1b-T2c (AJCC 7th Edition)
- •Clinical Nx or N0, and Mx or M0
- •PSA < 20 ng/mL
- •Low or intermediate risk according to NCCN guidelines: Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and PSA < 10 ng/ml; Intermediate: CS T2b-T2c and Gleason 2-6 and PSA < 10 ng/ml, or CS T1b-T2a and Gleason 7 and PSA < 10 ng/ml, or CS T1b-T2a and Gleason 2-6 and PSA 10-20ng/mL
- •ECOG performance status 0 or 1
- •Has had a pre-treatment PSA drawn within a month of the beginning of protocol therapy
- •If androgen-deprivation therapy (ADT) has been initiated, must have a documented pre-ADT PSA; this baseline PSA should not be obtained during following periods: 1) 10-day period following prostate biopsy; 2) within 30 days after discontinuation of finasteride; or 3) within 90 days after discontinuation of dutasteride.
- •Has completed a baseline health-related quality of life assessment Extended Prostate Cancer Index Composite questionnaire (EPIC-26)
- •Has had a history and physical examination (including digital rectal examination and a formal morbidity assessment via the ACE-27) within 60 days
- •Morbidity score (via the ACE-27) of none (0), mild (1) or moderate (2)
- •Willing and able to use adequate contraception during protocol treatment and for 3 months after the completion of protocol treatment
排除标准
- •Invasive (carcinoma in situ is allowed) solid or hematologic malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
- •Prior prostatectomy or cryotherapy of the prostate
- •Prior radiotherapy to the prostate or lower pelvis
- •Prior or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for a different cancer is allowed)
- •Implanted hardware near the planning target volume that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion
结局指标
主要结局
Biochemical disease-free survival
时间窗: 5-8 years
Biochemical Disease-Free Survival (bDFS), the time from completion of protocol treatment to the documented PSA rise of 2 ng/mL above the PSA nadir reached after treatment.
次要结局
- Grade 2 or higher acute gastrointestinal, genitourinary, and erectile toxicities(30 days from completion of protocol radiotherapy)
- Grade 3 or higher late gastrointestinal, genitourinary, and erectile toxicities(>30 days to 5 years from completion of protocol radiotherapy)
- Freedom from failure(5-8 years)
- Local recurrence-free survival(5-8 years)
- Distant disease-free survival(5-8 years)
- Cause-specific survival(5-8 years)
- Overall survival(8-10 years)
- Health-related quality of life(2-3 years)