Prospective Phase II Validation of the Performance of a Prostate-Specific Membrane Antigen (PSMA) Radiotracer for Positron Emission Tomography-Multiparametric Magnetic Resonance (PET-mpMR) Imaging to Target Prostate Biopsy Via Transrectal Ultrasound (TRUS) -Magnetic Resonance Imaging (MRI) Fusion Technique
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Discrimination of clinically significant prostate cancer (csPCa) from non-csPCa
研究概览
简要总结
This phase II trial evaluates an imaging technique called 18F-rhPSMA-7.3 positron emission tomography (PET)-multiparametric (mp) magnetic resonance imaging (MRI) in identifying tumor tissue in men suspected to have prostate cancer. This clinical trial also seeks to determine if the abnormal tissue identified during imaging represents the tumor tissue removed during transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy of the prostate. 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, 18F-rhPSMA-7.3. Because some tumors take up 18F-rhPSMA-7.3 it can be seen with PET. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Standard of care imaging for prostate cancer includes mpMRI, which is the combination of multiple magnetic resonance techniques, including diffusion weighted imaging, dynamic contrast-enhanced imaging, and spectroscopy, to achieve an image that will allow for better identification of tumor size and location, as well as possibly identifying tumor spread and aggressiveness. However, mpMRI may not be as effective in identifying prostate tumors that are clinically significant. A TRUS-MR biopsy involves using both ultrasound and MRI scans to locate abnormal areas in the prostate. An 18F-rhPSMA-7.3 PET-mpMRI may be more effective than mpMRI alone in identifying tumor tissue and may increase the accuracy of TRUS-MRI fusion biopsies in men suspected of having prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine if simultaneous flotufolastat F-18 gallium (18F-rhPSMA-7.3) PET-mpMR improves the detection of clinically significant prostate cancer (csPCa) in Prostate Imaging-Reporting and Data System (PI-RADS) ≥ 3 lesions.
SECONDARY OBJECTIVE:
I. To explore associations between radiomics textural data from the PET acquisition, mpMR imaging, or both with the presence of csPCa.
OUTLINE:
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
MR interpreters will be blinded to PET findings
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 subjects aged > 18 years
- •Patients with suspected prostate cancer who will have prostate biopsy for confirmation
- •Ability to lie still for MRI scanning
- •Patients must be able to provide written informed consent
排除标准
- •Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections
- •Patients with contraindications for MRI including implantable pace makers, cochlear implants
- •Patients with uni- or bilateral hip prosthesis
- •Subjects with other significant medical conditions that would create unacceptable prostate biopsy risk, compromise retention on study or compromise study related assessments
- •Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect PET-mpMR result
- •Is determined by the Investigator that the patient is clinically unsuitable for the study
- •Is incapable of understanding the language in which the information for the patient is given
- •Participation in a concurrent clinical trial or in another trial within the past 30 days
研究组 & 干预措施
Diagnostic (18F-rhPSMA-7.3 PET, mpMRI, TRUS-MR fusion biopsy)
Patients receive 18F-rhPSMA-7.3 IV and, 50 minutes later, undergo PET over 30 minutes at the time of SOC mpMRI. Patients may also undergo standard of care TRUS-MR fusion biopsy of targets identified on SOC mpMRI.
干预措施: Flotufolastat F-18 Gallium (Drug)
Diagnostic (18F-rhPSMA-7.3 PET, mpMRI, TRUS-MR fusion biopsy)
Patients receive 18F-rhPSMA-7.3 IV and, 50 minutes later, undergo PET over 30 minutes at the time of SOC mpMRI. Patients may also undergo standard of care TRUS-MR fusion biopsy of targets identified on SOC mpMRI.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (18F-rhPSMA-7.3 PET, mpMRI, TRUS-MR fusion biopsy)
Patients receive 18F-rhPSMA-7.3 IV and, 50 minutes later, undergo PET over 30 minutes at the time of SOC mpMRI. Patients may also undergo standard of care TRUS-MR fusion biopsy of targets identified on SOC mpMRI.
干预措施: Multiparametric Magnetic Resonance Imaging (Procedure)
Diagnostic (18F-rhPSMA-7.3 PET, mpMRI, TRUS-MR fusion biopsy)
Patients receive 18F-rhPSMA-7.3 IV and, 50 minutes later, undergo PET over 30 minutes at the time of SOC mpMRI. Patients may also undergo standard of care TRUS-MR fusion biopsy of targets identified on SOC mpMRI.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (18F-rhPSMA-7.3 PET, mpMRI, TRUS-MR fusion biopsy)
Patients receive 18F-rhPSMA-7.3 IV and, 50 minutes later, undergo PET over 30 minutes at the time of SOC mpMRI. Patients may also undergo standard of care TRUS-MR fusion biopsy of targets identified on SOC mpMRI.
干预措施: Transrectal Ultrasonography Guided Biopsy (Procedure)
结局指标
主要结局
Discrimination of clinically significant prostate cancer (csPCa) from non-csPCa
时间窗: Up to 3 months from imaging scan
Will determine if radiotracer activity within the sampled regions improves discrimination of csPCa from non-csPCa. The receiver operating characteristic and its associated area under the curve (AUC) for positron emission tomography standardized uptake value maximum will be estimated. To accommodate within-individual correlation among multiple lesions, 95% confidence intervals for the AUC will be obtained through bootstrap with re-sampling of patients.
次要结局
未报告次要终点
研究者
David M Schuster
Principal Investigator
Emory University