Radiotherapy With Hypofractionated Abdomino-Pelvic Salvage for Oligonodal Disease Study (RHAPSODY): MC1851 A Randomized, Parallel Phase II Trial Utilizing Proton Therapy or IMRT
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Incidence of late > grade 3 GI and/or GU toxicity
研究概览
简要总结
This phase II trial studies the side effects of radiation therapy [hypofractionated proton beam radiation therapy (PBRT) or intensity-modulated radiation therapy (IMRT)] for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionated PBRT delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. IMRT uses high energy x-rays to kill tumor cells and shrink tumors. This trial is being done to find out if a shorter course of radiation therapy is better with fewer side effects for patients with recurrent prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To assess late >= grade 3 gastrointestinal (GI) and/or genitourinary (GU) toxicity of interest within each treatment arm, moderate hypofractionation (MHF) and conventional fractionation (CF), delivered with PBRT or IMRT (late defined as 3 to 24 months after protocol radiation therapy [RT]).
SECONDARY OBJECTIVES:
I. Late grade >= 2 GI and/or GU toxicities of interest within 24 months after protocol treatment, using Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0.
II. Acute grade >= 3 GI and/or GU toxicities of interest during and within 3 months after the protocol treatment, using CTCAE v4.0.
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
- •Male; age >= 18 years
- •Histological confirmation of prostate adenocarcinoma
- •Recurrent prostate cancer after prior receipt of primary radiotherapy to the prostate [can also include treatment of seminal vesicles (SVs) and lymph nodes (LNs)] or salvage RT to the prostate fossa (can also include prior pelvic RT)
- •Oligometastatic extent of disease
- •Recurrent disease involving lymph nodes as diagnosed with choline positron emission tomography (PET)/computed tomography (CT) or other advanced PET imaging [prostate-specific membrane antigen (PSMA) or flucyclovine]
- •Limited to pelvic and/or retroperitoneal/para-aortic lymph nodes
- •Zubrod performance score (PS) =< 1
- •Signed informed consent
排除标准
- •Bone or visceral metastases present at the time of treatment (consolidative radiotherapy allowed)
- •Lymph node metastases beyond the pelvis and/or retroperitoneum
- •Contraindications to RT (e.g., uncontrolled inflammatory bowel disease)
- •Contraindications to androgen suppression
- •Concurrent cytotoxic chemotherapy
- •Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer
- •Inability to start the radiation portion of the protocol treatment within 6 months after study enrollment
- •Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up
研究组 & 干预措施
Arm II (conventional fractionation)
Patients undergo IMRT or PBRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm I (moderate hypofractionation)
Patients undergo photon IMRT or PBRT 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Questionnaire Administration (Other)
Arm I (moderate hypofractionation)
Patients undergo photon IMRT or PBRT 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Computed Tomography (Procedure)
Arm I (moderate hypofractionation)
Patients undergo photon IMRT or PBRT 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm I (moderate hypofractionation)
Patients undergo photon IMRT or PBRT 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
Arm I (moderate hypofractionation)
Patients undergo photon IMRT or PBRT 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Proton Beam Radiation Therapy (Radiation)
Arm I (moderate hypofractionation)
Patients undergo photon IMRT or PBRT 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Quality-of-Life Assessment (Other)
Arm I (moderate hypofractionation)
Patients undergo photon IMRT or PBRT 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm II (conventional fractionation)
Patients undergo IMRT or PBRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Computed Tomography (Procedure)
Arm II (conventional fractionation)
Patients undergo IMRT or PBRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm II (conventional fractionation)
Patients undergo IMRT or PBRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
Arm II (conventional fractionation)
Patients undergo IMRT or PBRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Proton Beam Radiation Therapy (Radiation)
Arm II (conventional fractionation)
Patients undergo IMRT or PBRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Quality-of-Life Assessment (Other)
Arm II (conventional fractionation)
Patients undergo IMRT or PBRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Incidence of late > grade 3 GI and/or GU toxicity
时间窗: Up to 24 months after RT
Assessed by the number of patients who experience a late (≥ 90 days after RT start date) grade 3 or higher gastrointestinal (GI) and/or genitourinary (GU) adverse event (AE) defined as possibly, probably, or definitely related to radiation therapy (RT). Adverse events will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
次要结局
- Incidence of late adverse events(Between 3 months and 2 years after completion of proton beam therapy)
- Incidence of acute adverse events(Up to 3 months after the completion of RT)
- Incidence of grade 3 or higher GI or GU adverse events per treatment schedule(Up to 60 months)
- Incidence of adverse events Incidence of adverse events Incidence of adverse events(Up to 60 months)