Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity
研究概览
简要总结
This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. Estimate the incidence of grade 2 gastrointestinal toxicity following the proposed treatment regimens at 2 years post-treatment.
SECONDARY OBJECTIVES:
I. Estimate the change in health related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment as defined by Expanded Prostate Cancer Index Composite (EPIC), Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire.
II. Estimate the rates of acute toxicity of the treatment regimens. III. Estimate the rates of late toxicity at 3, 4, and 5 years post-treatment. IV. Assess the efficacy of hypo-fractionated proton beam therapy, defined by the incidence of a rising prostate-specific antigen (PSA) at 5 years.
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 confirmed diagnosis of adenocarcinoma of the prostate within one year of study entry; evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson
- •History/physical examination with digital rectal examination of the prostate within 90 days prior to registration
- •Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material demonstrating Gleason score 2-7 within 365 days of registration
- •Clinical stage T1-2b (American Joint Committee on Cancer [AJCC] 7th edition) and PSA < 20 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
- •Zubrod performance status 0-1 within 90 days prior to registration
- •Patient must be able to provide study-specific informed consent prior to study entry
- •Willingness and ability to complete the EPIC questionnaire
排除标准
- •Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of 5 years
- •Evidence of distant metastases
- •Regional lymph node involvement
- •Previous prostatectomy, cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer
- •Previous pelvic radiation or prostate brachytherapy
- •Active and severe medical 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, active inflammatory bowel disease (Crohn's disease or ulcerative colitis), diagnosed connective tissue disorder, or congenital coagulation defects (patients on medical therapy with Coumadin or other blood thinning agents are eligible for participation)
研究组 & 干预措施
Treatment (proton beam radiation therapy)
Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (proton beam radiation therapy)
Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.
干预措施: Proton Beam Radiation Therapy (Radiation)
Treatment (proton beam radiation therapy)
Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity
时间窗: Up to 2 years post-treatment
The cumulative incidence of late grade 2 or greater GI toxicity will be estimated with a 95% confidence interval.
次要结局
- Change in health related quality of life (HRQOL) as assessed by the Expanded Prostate Cancer Index Composite (EPIC) Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire(Baseline to up to 5 years)
- Rates of acute toxicity(Within 90 days of treatment initiation)
- Rate of late toxicity(Up to 5 years post-treatment)
- Incidence of rising prostate-specific antigen (PSA)(At 5 years)
- Rate of local failure by biopsy(Up to 5 years)