Prospective Evaluation of Multi-Parametric MRI Guided Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity
研究概览
简要总结
This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify patients for two different radiotherapy regimens based on the presence/absence of identifiable intraprostatic lesions.
In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions (fractions) will be administered.
In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered followed by an SBRT prostate boost while simultaneously treating the prostate cancer lesion(s) to a higher dose in 3 fractions.
详细描述
Radiotherapy (RT) is considered standard of care treatment for prostate cancer. Conventional RT regimens consist of 8-9 weeks of daily RT. Recent data support the use of hypofractionated RT (5-6 weeks) due to similar disease control in a contracted treatment time. This study combines the benefits of RT dose escalation while shortening the overall RT treatment course.
In this protocol, patients will undergo a pretreatment mpMRI prostate scan and be stratified to two separate SBRT regimens depending on whether prostate lesions are present. For patients without any positive mpMRI lesions, an SBRT monotherapy (36.25 Gy in 5 fractions) approach will be utilized. Patients with an equivocal or positive mpMRI lesion(s), will receive IG-IMRT (45 Gy in 25 fractions) to prostate and seminal vesicle +/- lymph nodes followed by a SBRT whole prostate boost (18 Gy in 3 fractions) with a simultaneously integrated boost (SIB) (21 Gy in 3 fractions) to intraprostatic lesion(s) only.
Patients will be regularly assessed every 3 months for the first 2 years and then every 6 months, indefinitely. Side effects will be monitored using the standardized international prostate symptom score (I-PSS) and Sexual Health Inventory of Men (SHIM) questionnaires at baseline and subsequent follow-up appointments.
Hypothesis
MRI-guided treatment planning and delivery can selectively target high-risk prostate cancer nodules and deliver a higher effective RT dose, to achieve maximal tumor control without increasing toxicity, all in a shortened treatment duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Biopsy proven prostate adenocarcinoma within 1 year of randomization
- •NCCN Low to High Risk localized prostate cancer
- •Zubrod Performance Status 0-1 within 60 days prior to registration
排除标准
- •Prior or concurrent invasive malignancy (except non-melanoma skin cancer)
- •Regional Lymph Node (N1) involvement
- •Distant Metastases (M1) involvement
- •History of prior pelvic irradiation (external beam radiotherapy or brachytherapy)
- •Prior chemotherapy
- •Severe, active co-morbidities (unstable angina and/or CHF; MI; COPD; liver disease; AIDS)
- •Acute bacterial or fungal infection requiring IV antibiotics
- •Inability to undergo MRI
- •Inability to receive fiducial markers
研究组 & 干预措施
Negative mpMRI Prostate Scan
SBRT to the whole prostate
干预措施: SBRT to whole prostate (Radiation)
Positive mpMRI Prostate Scan
IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions
干预措施: IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions (Radiation)
结局指标
主要结局
Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity
时间窗: 18 months
Number of Participants with late grade 3-5 genitourinary and gastrointestinal toxicity following mpMRI guided radiation treatment. Late toxicity will be defined as toxicity occurring more than nine months from the start of radiotherapy.
次要结局
- Biochemical Recurrence(18 months)
- Number of Participants With Acute Radiation Induced Genitourinary Adverse Event(3 months)
- Disease Free-Survival(18 months)
研究者
Dian Wang
Principal Investigator
Rush University Medical Center