Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of PSMA-PET scan in identifying recurrent prostate cancer after focal therapy
研究概览
简要总结
To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy
详细描述
PSMA is a protein that is highly expressed in prostate cancer cells, making it an excellent specific target for imaging with PET scans that can provide detailed information about the location, extent and aggressiveness of prostate cancer lesions. These scans have proven invaluable for identifying and characterizing prostate cancer, aiding in treatment planning, and Monitoring treatment response. It's true and fully utility in focal therapy for prostate cancer is unknown.
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
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
- •Adult males 18 years or older;
- •Patient must have a pre-treatment MRI;
- •Patient underwent SOC focal therapy with either focal or hemiablation for the treatment of intermediate risk prostate cancer in the past 9 months prior to enrollment;
- •Intermediate risk disease as defined by American Urology Academy (AUA)/National Comprehensive Cancer Network (NCCN) guidelines (see Appendix A)
- •Life Expectancy of 10 years or more;
- •Underwent standard template biopsy before treatment with a minimum of 2 cores into the MRI visible lesion if lesion was present;
- •Patient understands the purpose of the trial and procedures required for the trial, and can provide signed informed consent as which includes compliances with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol; and
- •Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and test specimen (blood sample) collection at specified time points.
排除标准
- •Patients under the age of 18 will be considered pediatric patients and will not be included in this study because they are thought to represent a unique population outside the scope of this study as it is aimed at identifying factors that affect adults only.
- •Patients previously treated with whole gland ablation or prior partial gland ablation over 9 months prior to enrollment.
研究组 & 干预措施
18F-rhPSMA-7.3
Patients will undergo a PSMA-PET scan at 1 year (+/- 60 days) after treatment with SOC focal therapy using a radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)-targeted PET scan using 18F-rhPSMA-7.3 (Posluma).
The rhPSMA-targeted PET scan is an FDA-approved PET scan to detect the presence of lesions positive for prostate-specific membrane antigen (PSMA) in men with prostate cancer. 18F-rhPSMA-7.3 (Posluma) injection is a radioactive diagnostic agent that is administered in the form of an intravenous injection.
干预措施: 18F-rhPSMA-7.3 (Drug)
结局指标
主要结局
To evaluate the effectiveness of PSMA-PET scan in identifying recurrent prostate cancer after focal therapy
时间窗: Approximately 1 year after SOC focal therapy.
All patients will get a biopsy to assess the effectiveness of treatment at 1 year, which is standard protocol at our institutions (all patients undergo biopsy at year 1 and 3 at our institutions). The post-treatment PSMA-PET scan will be correlated to 1-year biopsy results to study the utility of such a scan. Recurrence is defined by a positive PSMA-PET scan and positive biopsy in the area of PET scan tracer uptake at 1 year after SOC focal treatment.
次要结局
- To report the sensitivity and specificity in evaluating PSMA-PET scan(Approximately 1 year after SOC focal therapy.)