Beacon: Prospective Assessment of Flotufolastat F 18 PSMA and MRI in the Diagnosis of Clinically Significant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Detection of high-grade cancer (grade group [GG] ≥ 2)
研究概览
简要总结
This early phase I trial evaluates whether a new imaging technique using flotufolastat F 18 (a type of prostate specific membrane antigen [PSMA] imaging agent) with positron emission tomography (PET)/computed tomography (CT) can be used to guide targeted prostate biopsies in men with prostate cancer. Flotufolastat F 18 is a radioactive imaging agent that binds to prostate tumor cells that express PSMA. This allows for visualization of PSMA-expressing tumor cells on imaging scans such as PET/CT. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, flotufolastat F 18. Because prostate cancer takes up flotufolastat F 18, it can be seen with PET. CT utilizes X-rays that track the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. The PET/CT scanner combines the PET and the CT scanners into a single device. A targeted prostate biopsy refers to using advanced imaging for guidance when taking samples (biopsies) of the prostate. This method can fuse (combine) PET/CT images with real-time ultrasound during a prostate biopsy. PSMA PET/CT scans have the potential for guiding prostate biopsies. Using image fusion technology, they can increase detection of prostate cancer by providing anatomical information and guidance during a prostate biopsy. Improved detection of prostate cancer using PSMA PET/CT guidance may better inform men and their clinicians about prostate cancer risk and management. This study attempts to determine how often prostate cancer is found when using PSMA PET/CT scan images during a biopsy versus the conventional magnetic resonance imaging-guidance.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the detection rate of flotufolastat F 18 and magnetic resonance imaging (MRI) regions of interest for grade group 2 and greater prostate cancer.
SECONDARY OBJECTIVES:
I. Evaluate the detection rate of incidental grade group (GG)1 prostate cancer (region of interest [ROI] benign, systematic GG1).
II. Evaluate the patient-level GG ≥ 2 detection rate for increasing standardized uptake value (SUV) and Prostate Imaging-Reporting and Data System (PI-RADS) score to determine if/when systematic biopsy may be omitted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Nuclear medicine physicians will initially be blinded to MRI findings while interpreting and outlining the PSMA PET/CT.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 18-90 at study enrollment
- •Have at least one PI-RADS 3-5 lesion on MRI within the 12 months prior to enrollment
排除标准
- •Contraindication to flotufolastat F 18 PET CT
- •Contraindication to ultrasound-guided prostate biopsy
- •Previous treatment of prostate cancer
- •Unable to discontinue blood thinners for 7 days prior to biopsy
- •Any investigational agents within 42 days prior to the day of the first dose
- •Not able to understand and to follow study instructions and requirements. This also includes the inability to complete the study imaging and or biopsy procedures due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time, any condition that precludes raised arms position)
研究组 & 干预措施
Diagnostic (flotufolastat F-18 PET/CT)
Patients receive flotufolastat F-18 IV and then, 50-100 minutes later, undergo PET/CT over 30 minutes. Within 6 months of PET/CT imaging, patients undergo PSMA PET/CT/US fusion biopsy and MRI/US fusion biopsy in a randomized order. Patients may undergo blood sample collection at screening and/or on study.
干预措施: Biopsy of Prostate (Procedure)
Diagnostic (flotufolastat F-18 PET/CT)
Patients receive flotufolastat F-18 IV and then, 50-100 minutes later, undergo PET/CT over 30 minutes. Within 6 months of PET/CT imaging, patients undergo PSMA PET/CT/US fusion biopsy and MRI/US fusion biopsy in a randomized order. Patients may undergo blood sample collection at screening and/or on study.
干预措施: Biospecimen Collection (Procedure)
Diagnostic (flotufolastat F-18 PET/CT)
Patients receive flotufolastat F-18 IV and then, 50-100 minutes later, undergo PET/CT over 30 minutes. Within 6 months of PET/CT imaging, patients undergo PSMA PET/CT/US fusion biopsy and MRI/US fusion biopsy in a randomized order. Patients may undergo blood sample collection at screening and/or on study.
干预措施: Computed Tomography (Procedure)
Diagnostic (flotufolastat F-18 PET/CT)
Patients receive flotufolastat F-18 IV and then, 50-100 minutes later, undergo PET/CT over 30 minutes. Within 6 months of PET/CT imaging, patients undergo PSMA PET/CT/US fusion biopsy and MRI/US fusion biopsy in a randomized order. Patients may undergo blood sample collection at screening and/or on study.
干预措施: Flotufolastat F-18 Gallium (Radiation)
Diagnostic (flotufolastat F-18 PET/CT)
Patients receive flotufolastat F-18 IV and then, 50-100 minutes later, undergo PET/CT over 30 minutes. Within 6 months of PET/CT imaging, patients undergo PSMA PET/CT/US fusion biopsy and MRI/US fusion biopsy in a randomized order. Patients may undergo blood sample collection at screening and/or on study.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Detection of high-grade cancer (grade group [GG] ≥ 2)
时间窗: At time of biopsy
Results of prostate specific membrane antigen (PSMA)- and magnetic resonance imaging (MRI)-guided biopsy will be compared to the results of systematic biopsy in the same patient.
次要结局
- Proportion of subjects with incidental GG1 prostate cancer detected through systematic biopsy when the region of interest is benign on MRI and PSMA-positron emission tomography (PET)(At time of biopsy)
- Rate of detection of GG ≥ 2 prostate cancer in relation to increasing standardized uptake value and Prostate Imaging-Reporting and Data System scores(At time of biopsy)
- Accuracy and predictive value of the MRI + PSMA-PET composite score for detecting clinically significant prostate cancer during biopsy(At time of biopsy)
- Percentage of cases where the intraprostatic tumor location identified by MRI-guided and PSMA-guided biopsies matches(At time of biopsy)