Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Early Genitourinary and Gastrointestinal Toxicity
研究概览
简要总结
The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.
详细描述
PSMA-PET is highly sensitive and specific for detecting prostate cancer. PSMA-PET and mpMRI can potentially help guide target volumes for patients with unfavorable-risk prostate cancer receiving radiation by designing a radiation treatment plan so that the entire prostate receives the prescribed dose of radiation in addition to the visible tumor in the prostate as detected by mpMRI and/or PSMA-PET receiving any inevitable intrinsic plan "hot spots" or areas of dose above the prescription.
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
- •Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- •Histologically confirmed prostate adenocarcinoma
- •Unfavorable intermediate or high-risk, based on the National Comprehensive Cancer Network (NCCN) criteria, with appropriate staging (e.g. bone scan) as defined in the protocol.
- •Subject has adequate performance status as defined by ECOG performance status of 0-
- •Subject is willing and able to comply with the protocol as determined by the Treating Investigator.
- •Subject speaks English (quality of life instrument is validated in English).
排除标准
- •Contraindications for MRI
- •Other prior or concomitant malignancies with the exception of:
- •Non-melanoma skin cancer
- •Other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence.
- •Inflammatory bowel disease
- •Absolute contraindications to brachytherapy per American Brachytherapy Society: unacceptable operative risk, absence of rectum, large TURP defects
研究组 & 干预措施
PMSA-PET/MRI
Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment
干预措施: 68Ga-HBED-CC-PSMA (Drug)
结局指标
主要结局
Early Genitourinary and Gastrointestinal Toxicity
时间窗: Up to 22 weeks (3 months after completion of radiation therapy)
Grade 3 or higher early genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop within three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
次要结局
- Late Genitourinary Toxicity After Radiation(Three months after starting radiation therapy to up to 48 months post-treatment)
- Biochemical Control Using Prostate-Specific Antigen (PSA) Levels(At 2 years after radiation therapy)
- Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Bowel Domain(At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy)
- The Number of Participants Started Study.(Baseline)
- Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) Rectal Domain(At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy)
- Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) - Urinary Domain(At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy)
- Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Hormonal Function Domain(At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy)
- Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) -Sexual Function Domain(Baseline and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy)
- Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Urinary Incontinence, Urinary Irritation Domains(at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy)