A Phase I Feasibility Study of Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR Image-Guided, Intensity-Modulated Radiotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 14
- 主要终点
- Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
研究概览
简要总结
The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate cancer.
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
- •Intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate risk patients will be defined as:
- •PSA 10-20 ng/ml or
- •Gleason score = 7 or
- •Clinical stage T2b/T2c
- •Additionally, patients will be required to meet the following criteria:
- •KPS > 80
- •Prostate size < 60cc
- •Presence of a prostatic lesion with maximum dimension of >/= 0.5cm and no more than two additional disease foci, each with a maximum dimension less than that of the dominant lesion.
- •International Prostrate Symptom Score < 15
- •Subjects must fill out the standard MRI screening form and satisfy all MRI screening criteria
排除标准
- •Prior androgen deprivation therapy for prostate cancer
- •Evidence of metastatic disease on bone scan or MRI/CT
- •MRI ineligibility due to the presence of a cardiac pacemaker, defibrillator or other implanted metallic or electronic device which is considered MR unsafe, severe claustrophobia or inability to lie flat for the duration of the study, etc.
- •Metallic hip implant, metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MP-MRI.
- •Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
- •Contra-indications to receiving gadolinium contrast
- •KPS < 80
- •Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease.
- •Prior history of transurethral resection of the prostate
- •Prior history of chronic prostatitis
- •Prior history of urethral stricture
- •Prior history of pelvic irradiation
- •History of inflammatory bowel disease
- •Unable to give informed consent
- •Unable to complete quality of life questionnaires
- •Abnormal complete blood count. Any of the following
- •Platelet count less than 75,000/ml
- •Hb level less than 10 gm/dl
- •WBC less than 3.5/ml
- •Abnormal renal function tests (creatinine > 1.5)
研究组 & 干预措施
MR Image Guided, Intensity-Modulated Radiotherapy
Patients enrolled in this study will undergo MR-based, image-guided, intensity-modulated radiotherapy using similar equipment, techniques, and treatment-planning procedures as currently practiced at MSKCC.
干预措施: MR-based image-guided, intensity-modulated radiotherapy (Radiation)
结局指标
主要结局
Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
时间窗: 36 months
Assess toxicity of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostate cancer. Severe Toxicity will be assessed and defined as Grade 3 or higher NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
次要结局
未报告次要终点