A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
- 试验地点
- 101
- 主要终点
- Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item scores
研究概览
简要总结
This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes [quality of life (QOL), toxicity, and disease control] between parallel cohorts of men with prostate cancer treated simultaneously at proton therapy facilities and at geographically similar conventional (photon-based) radiation facilities using intensity-modulated radiation therapy (IMRT) techniques.
详细描述
This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes [quality of life (QOL), toxicity, and disease control] between parallel cohorts of men with prostate cancer treated simultaneously at proton therapy facilities and at geographically similar conventional (photon-based) radiation facilities using intensity-modulated radiation therapy (IMRT) techniques. This study includes a pre-specified randomized comparison of standard fractionation and moderate hypofractionation dose schemes within the proton therapy cohort. In addition, subgroup analyses will include a comparison of outcomes by race (Black vs. White), comorbidity score (0 vs. 1+), age (<65 vs. ≥65), fractionation schedule (standard, moderate, ultra-hypofractionation), and prostate cancer aggressiveness (very low and low, intermediate, and high risk) for all objectives.
All interventions will be standard of care (SOC) radiation strategies using either IMRT or proton therapy. All patient-reported QOL, patient-scored and patient-reported toxicity, and disease control assessments will be SOC. Participants will also complete pretreatment surveys regarding demographic data, personal treatment goals, factors affecting treatment decision-making, and sources of information used in treatment selection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of adenocarcinoma of the prostate.
- •30-85 years of age at the time of consent with a life expectancy estimation (LEE) of ≥ 8 years.
- •Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE with or without mpMRI, and clinical stage.
- •Very low-risk, low-risk, intermediate-risk, or high-risk disease based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.
- •If patient has high-risk disease, nuclear medicine bone imaging must be performed to document the absence of overt metastatic disease in bones.
- •ECOG/Zubrod Performance Status 0 -
- •Candidate for definitive prostate radiotherapy (either IMRT or proton).
- •If patient is to be treated with IMRT, all treatment must be planned with IMRT; if patient is to be treated with protons, all treatment must be planned with protons (including pelvic nodes if treated).
排除标准
- •Findings of metastatic disease (nodal or distant, N1 or M1).
- •Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.
- •Prior procedures for treatment of prostate cancer, such as radical or robotic prostatectomy, high-intensity focused ultrasound, cryosurgery, or focal prostatectomy [note that procedures used for benign prostatic hyperplasia symptoms, such as transurethral resection of the prostate (TURP) and GreenLight Laser Therapy, are acceptable].
- •Previous prostate cancer treatment with the exception of ADT according to NCCN guidelines.
- •History of invasive rectal malignancy or other malignancy in the true pelvis (e.g. bladder, rectum, or reproductive organs), regardless of disease-free interval.
- •Active inflammatory bowel disease (i.e., patients requiring medical interventions or who are symptomatic).
- •Prior pelvic RT for any reason.
- •Documented lack of psychological ability or general health permitting completion of the study requirements and required follow-up.
- •Documented diminished capacity to understand the risks and benefits of participation in research and to autonomously provide informed consent.
- •In addition, because the embedded randomized controlled trial compares fractionation schemes, patients who are receiving pelvic node irradiation may not be enrolled on the randomized controlled trial.
研究组 & 干预措施
IMRT (Photon)
As this trial is pragmatic, all treatment will be standard of care.
干预措施: Standard of Care IMRT (Photon) (Radiation)
Proton Therapy Standard of Care
As this trial is pragmatic, all treatment will be standard of care.
干预措施: Standard of Care Proton Therapy (Radiation)
Standard Proton Therapy
78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.
干预措施: Proton Arm 1: Standard Proton Therapy (Radiation)
Hypofractionated Proton therapy
60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.
干预措施: Proton Arm 2: Hypofractionated Proton Therapy (Radiation)
结局指标
主要结局
Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item scores
时间窗: 2-years after the end of radiation therapy
EPIC assesses the disease-specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal). Factor analysis supports dividing the Urinary Domain Summary Score into two distinct Incontinence and Irritative/Obstructive subscales. In addition, each Domain Summary Score has measurable Function Subscale and Bother Subscale components. Response options for each EPIC item form a Likert scale, and multi-item scale scores are components. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL
次要结局
- Grade 2 or higher toxicity for each adverse event assessed by CTCAE(2-years after the end of radiation therapy)
- Freedom from biochemical progression using PSA results.(3-years after the end of radiation therapy)
- Grade 2 or higher toxicity for each adverse event assessed by PRO-CTCAE.(2-years after the end of radiation therapy)