LCCC 1917: Dose Escalation of Low and Intermediate Risk Localized Prostate Cancer Using 68Ga-HBED-CC PSMA-PET/MRI and Stereotactic Body Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Genitourinary and gastrointestinal toxicity 12 months post-treatment
研究概览
简要总结
The goal of this study is to determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant intra-prostatic lesions while meeting all current planning criteria.
详细描述
This study aims to determine if multi-parametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging can help optimize the placement of the high dose inhomogeneity characterizing stereotactic body radiation therapy. All radiation plans have "hot spots" of radiation, and in current practice these regions are randomly located. This study will focus those hot spots on regions determined by mpMRI + PSMA-PET to have visible tumor.
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
- •Male subjects ≥ 18 years of age
- •Histologically confirmed prostate adenocarcinoma
- •Low or favorable intermediate risk, based on the NCCN criteria
- •Subject has adequate performance status as defined by ECOG performance status of 0-2
- •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
- •Previous transurethral resection of the prostate (TURP) or surgery of the prostate
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
Genitourinary and gastrointestinal toxicity 12 months post-treatment
时间窗: Baseline to 1 year post-treatment
Grade 2+ GU/GI late toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 at 12 months after radiation therapy
Feasibility of meeting specified dose constraints
时间窗: Baseline to 1 year post-treatment
Proportion of subjects who meet these criteria: * Boost dose coverage: DIL D95% ≥ 44 Gy * Dose constraints: Urethra Dmax \< 40 Gy Bladder Dmax \< 45.6 Gy Bladder D10cc \< 41.8 Gy Rectum Dmax \< 38 Gy Rectal Mucosa D1% \< 28.5 Gy Sigmoid Colon Dmax \< 28.5 Gy
次要结局
- Acute and late genitourinary and gastrointestinal toxicity(Baseline to 5 years post-treatment)
- Biochemical control using Prostate-Specific Antigen (PSA) levels(Baseline to 5 years post-treatment)
- Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26)(Baseline to 5 years post-treatment)
- Screened Subjects(Through study completion, average of 2 years)
- Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI)(Baseline to 5 years post-treatment)