Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute grade 2+ gastrointestinal (GI) toxicity
研究概览
简要总结
This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy.
详细描述
PRIMARY OBJECTIVE:
I. To determine the rate of acute grade 2+ gastrointestinal toxicity compared to historical photon treatments.
SECONDARY OBJECTIVES:
I. To determine the rate of acute grade 2+ genitourinary toxicity compared to historical photon treatments.
II. To assess the feasibility of extended-field proton irradiation of high-risk prostate.
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
- •Pathologically confirmed high-risk prostate cancer fulfilling any one of the following criteria:
- •Gleason grade 8 or higher
- •cT3b (seminal vesicle involvement) or cT4
- •Prostate specific antigen [PSA] > 20 (or PSA >10 if on finasteride)
- •Clinically or pathologically positive regional lymph nodes within the inguinal, external iliac, internal iliac, obturator, peri-rectal, pre-sacral, common iliac, or lower para-oaortc (inferior to the L2-L3 interspace) basins
- •Zubrod performance status 0-2
- •Complete blood cell (CBC)/differential obtained within 90 days prior to registration on study
- •Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
- •Platelets >= 100,000 cells/mm^3
- •Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
- •Patient must be able to provide study specific informed consent
排除标准
- •Absence of bone metastasis by bone scan or metabolic imaging (e.g. NaF PET, FACBC PET, PSMA PET, etc.) before the start of therapy.
- •Absence of distant lymph node metastasis by CT and/or MRI before the start of therapy.
- •Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- •Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
- •Uncontrolled intercurrent illness including, but not limited to, inflammatory bowel disease, human immunodeficiency virus infection, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
Treatment (proton beam therapy)
Patients undergo conventionally fractionated or hypofractionated proton beam therapy daily on Monday-Friday directed to the prostate, pelvic lymph nodes, and para-aortic lymph nodes. Patients may receive an optional high-dose rate brachytherapy boost. Androgen deprivation therapy is required but left to the discretion of the treating physician.
干预措施: High-Dose Rate Brachytherapy (Radiation)
Treatment (proton beam therapy)
Patients undergo conventionally fractionated or hypofractionated proton beam therapy daily on Monday-Friday directed to the prostate, pelvic lymph nodes, and para-aortic lymph nodes. Patients may receive an optional high-dose rate brachytherapy boost. Androgen deprivation therapy is required but left to the discretion of the treating physician.
干预措施: Proton Beam Radiation Therapy (Radiation)
Treatment (proton beam therapy)
Patients undergo conventionally fractionated or hypofractionated proton beam therapy daily on Monday-Friday directed to the prostate, pelvic lymph nodes, and para-aortic lymph nodes. Patients may receive an optional high-dose rate brachytherapy boost. Androgen deprivation therapy is required but left to the discretion of the treating physician.
干预措施: Quality-of-Life Assessment (Other)
Treatment (proton beam therapy)
Patients undergo conventionally fractionated or hypofractionated proton beam therapy daily on Monday-Friday directed to the prostate, pelvic lymph nodes, and para-aortic lymph nodes. Patients may receive an optional high-dose rate brachytherapy boost. Androgen deprivation therapy is required but left to the discretion of the treating physician.
干预措施: Survey Administration (Other)
结局指标
主要结局
Acute grade 2+ gastrointestinal (GI) toxicity
时间窗: Up to 3 years
The rate of grade 2+ gastrointestinal toxicity within 30 days of receiving radiation therapy (RT) will be measured. It will be compared to the theorized reduction to 24% toxicity using the exact binomial test. Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GI toxicity will be assessed.
次要结局
- Acute grade 2+ genitourinary (GU) toxicity rate(Up to 3 years)
- Optimal frequency of cone beam computed tomography (CT)(Through study completion, an average of 1 year)
- Patient reported health related quality of life (QOL) - EPIC-CP(Up to 3 years)
- Patient reported health related quality of life (QOL) - PRO-CTCAU GU(Up to 3 years)
- Patient reported health related quality of life (QOL) - IPSS(Up to 3 years)
- Chronic GI Toxicity(Up to 3 years)
- Patient reported health related quality of life (QOL) - PRO-CTCAU GI(Up to 3 years)
- Chronic GU Toxicity(Up to 3 years)
- Biochemical failure(Baseline up to pre-RT)
研究者
Pretesh Patel
Principal Investigator
Emory University