Randomized Phase III Trial of Rapid-Plan Knowledge-Based Planning vs. Human-Driven Planning for Prostate Cancer Radiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Incidence of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events (AEs)
研究概览
简要总结
This phase III trial compares the effects of radiation therapy using RapidPlan, trademark, knowledge-based planning to human-driven planning in treating patients with prostate cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Successful delivery of radiation requires planning to develop a treatment plan for how and where the radiation is to be delivered. RapidPlan is a knowledge-based treatment planning tool that automatically creates an optimal treatment plan based on identified targets and organs at risk for radiation exposure. Human-driven treatment planning by a dosimetrist, the current standard of care, requires significant resources and time and may vary within and among radiation centers. Giving radiation therapy with RapidPlan knowledge-based planning may have similar or less side effects compared to human-driven planning in treating patients with prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine if RapidPlan knowledge-based planning is non-inferior to human-driven planning regarding treatment-related rates of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events at 3 months post-radiotherapy for prostate cancer.
EXPLORATORY OBJECTIVES:
I. After completion of radiation therapy, determine the incidence of:
Ia. Grade 2 or greater GU and GI toxicity at 3 months (Common Terminology Criteria for Adverse Events [CTCAE] version 5); Ib. Quality of life 3 months post-radiotherapy; Ic. Rate of achieving dose-volume constraints. II. Determine if there are any statistical differences in dose-volumes results with RapidPlan knowledge-based planning.
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
- •Patients must be at least 18 years old
- •Histologically confirmed prostate cancer
- •Clinical or pathologic stages T1c-T3b, Nx or N0-1, M0-1 (American Joint Committee on Cancer [AJCC] criteria 8th edition [Ed])
- •Planned definitive dose radiotherapy to the prostate or prostate bed
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment
- •Patients must sign Institutional Review Board (IRB) approved study specific informed consent
- •Patients must complete all required pre-entry tests within the specified time frames
- •Patients must be able to start treatment (radiation) within 180 days of study registration
- •In case of confusion about the eligibility or ineligibility of an individual patient, the principal investigator (PI) can be used as the arbiter and a note to file will be added to the subject's regulatory binder to document outcome
排除标准
- •Previous pelvic radiation > 5 Gy
- •Planned delivery of radiotherapy to pelvic lymph nodes
- •Planned delivery of brachytherapy of the prostate
- •Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
- •Prior hip replacement or penile implant
- •Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (consent by legal authorized representative is not permitted for this study)
- •Indwelling or intermittent urinary catheter use
研究组 & 干预措施
Arm B (RapidPlan treatment planning, radiation therapy)
Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Biospecimen Collection (Procedure)
Arm A (human-driven treatment planning, radiation therapy)
Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Biospecimen Collection (Procedure)
Arm A (human-driven treatment planning, radiation therapy)
Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm A (human-driven treatment planning, radiation therapy)
Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Photon Beam Radiation Therapy (Radiation)
Arm A (human-driven treatment planning, radiation therapy)
Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Positron Emission Tomography (Procedure)
Arm A (human-driven treatment planning, radiation therapy)
Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Questionnaire Administration (Other)
Arm A (human-driven treatment planning, radiation therapy)
Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Radiation Therapy Treatment Planning and Simulation (Radiation)
Arm B (RapidPlan treatment planning, radiation therapy)
Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm B (RapidPlan treatment planning, radiation therapy)
Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Photon Beam Radiation Therapy (Radiation)
Arm B (RapidPlan treatment planning, radiation therapy)
Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Positron Emission Tomography (Procedure)
Arm B (RapidPlan treatment planning, radiation therapy)
Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Questionnaire Administration (Other)
Arm B (RapidPlan treatment planning, radiation therapy)
Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
干预措施: Radiation Therapy Treatment Planning and Simulation (Radiation)
结局指标
主要结局
Incidence of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events (AEs)
时间窗: Up to 3 months post-radiotherapy
AEs will be defined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Comparisons between treatment arms will be made using a non-inferiority test for the difference between two proportions with an alpha level of 5%. The proportion of patients experiencing grade 3 or higher GU or GI AEs over the number of patients eligible for toxicity will be estimated.
次要结局
未报告次要终点