Evaluation of Patients With Low-Risk and Intermediate-Risk Prostate Cancer Scheduled for High-Dose Rate Brachytherapy Using 68-Ga-RM2 PET, 68Ga-PSMA-11 PET and Multi Parametric MRI
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer (PC)
详细描述
Primary Objective:
- To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI.
- To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment and predict progression free survival (PFS) at 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 of age;
- •Patients must be able to provide informed consent;
- •Histologically proven low-grade or intermediate-grade prostate cancer (PC)
- •Scheduled to undergo targeted local therapy (HDR brachytherapy).
排除标准
- •Inability to lie still for the entire imaging time;
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
- •Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance;
- •Metallic implants (contraindicated for MRI).
研究组 & 干预措施
68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI
Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
干预措施: 68-Ga RM2. (Drug)
68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI
Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
干预措施: 68-Ga PSMA11 (Drug)
68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI
Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
干预措施: PET/MRI (Device)
68Ga-PSMA-11 PET MRI then 68Ga-RM2 PET MRI
Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
干预措施: 68-Ga RM2. (Drug)
68Ga-PSMA-11 PET MRI then 68Ga-RM2 PET MRI
Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
干预措施: 68-Ga PSMA11 (Drug)
68Ga-PSMA-11 PET MRI then 68Ga-RM2 PET MRI
Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
干预措施: PET/MRI (Device)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 24 months
Progression-free survival (PFS) will be assessed as survival without progression at 24 months. The outcome is reported as the number (without dispersion) of the participants alive without progression.
Number of Participants With Successful Assessment of PET Based PC Lesions
时间窗: Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment
Assessment of whether 68-Ga-RM2 and 68-Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI. Detection of PC lesions will be assessed by 68Ga PSMA11 and 68Ga RM2 PET scans.
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HDR is Successfully Obtained
时间窗: Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment
Assessment of whether 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment. Therapeutic response to HDR will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
未报告次要终点
研究者
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Stanford University