Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of patients with change in EPIC bowel domain score that was worse than 5 points
研究概览
简要总结
This pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the correlation of histopathology findings in comparison to regions of the prostate reported to be suspicious for harboring tumor burden on multiparametric MRI report/s.
II. Demonstration of the dosimetric and radiobiological advantages of focal stereotactic body radiation therapy (SBRT) versus whole-gland radiation therapy.
III. Evaluation of clinical outcomes in focal SBRT for localized prostate cancer.
OUTLINE:
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
- •Patients must have a histologically confirmed diagnosis of adenocarcinoma of the prostate
- •Patient must have a history/physical examination with digital rectal examination of the prostate within 90 days prior to screening
- •Eastern Cooperative Oncology Group (ECOG) performance status must be level 0 or 1 within 60 days prior to registration
- •Patient must have a histological evaluation of the prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores ≤ 7(3+4)
- •Serum creatinine ≤ 1.5 times upper limit of institutional normal (normal: ≤ 1.17 mL/min/1.73 m^2)
- •Clinical stage a ≤ T1-T2a (American Joint Committee on Cancer [AJCC] 7th edition)
- •Prostate specific antigen (PSA) ≤ 10 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document
- •Patient willing and able to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire (baseline, 6, 12 and 24 months post end of radiation therapy)
- •Patients must be able to undergo an MRI with contrast
- •Bone scan completed within 90 days
排除标准
- •Evidence of distant metastases
- •Regional lymph node involvement
- •Previous radical surgery (prostatectomy), cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer
- •Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- •Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol [DES]), or surgical castration (orchiectomy)
- •Use of finasteride within 30 days prior to registration; PSA should not be obtained prior to 30 days after stopping finasteride
- •Use of dutasteride within 90 days prior to registration; PSA should not be obtained prior to 90 days after stopping dutasteride
- •Previous or concurrent cytotoxic chemotherapy for prostate cancer
- •Severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study)
- •Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
- •Patients unable to undergo an MRI with contrast
结局指标
主要结局
Number of patients with change in EPIC bowel domain score that was worse than 5 points
时间窗: Up to 1 year from start of study
Number of patients with change in EPIC bowel domain score that was worse than 5 points A rate for the worse-than-5 point change in bowel score of up to 35% of patients will be considered acceptable, with a rate ≥55% specified as unacceptable
Number of patients with change in EPIC urinary domain score that was worse than 2 points
时间窗: Up to 1 year from start of study
Number of patients with change in EPIC urinary domain score that was worse than 2 points A rate for the worse-than-2 point change in urinary score of up to 40% will be considered acceptable, with a rate ≥60% unacceptable
次要结局
- Time to local progression(Up to 2 years from start of study)
- PSA response(Up to 2 years from start of study)
- Number of acute gastrointestinal (GI) grade 3+ acute adverse events, evaluated by the Cancer Therapy Evaluation Program (CTEP) active version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)(Up to 30 days after the completion of radiation therapy)
- Number of late GU grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE(Up to 2 years from start of study)
- Number of patients with Disease-free survival(Up to 2 years from start of study)
- Time to distant failure(Up to 2 years from start of study)
- Number of acute genitourinary (GU) grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE(Up to 2 years from start of study)
- Number of late GI grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE(Up to 2 years from start of study)