RhPSMA-7.3(18F)-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- AdventHealth
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cancer Detection Rate
研究概览
简要总结
Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer.
The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
详细描述
This is not an investigational study drug. Flotufolastat PET scan is FDA Approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. In this research study, the flotufolastat-PET scan will be repeated if the initial scan does not show cancer and if PSA further rises by greater than 0.1 ng/ml. Other currently used scans for this purpose do not detect cancer in all patients with low levels of rising PSA.
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
- •History of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy.
- •An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5
排除标准
- •Patients who are planned to have an x-ray contrast agent or other PET radiotracer & less than 24 hours prior to the flotufolastat F-18 PSMA-PET scan.
- •Patients currently receiving Androgen Deprivation Therapy (ADT).
研究组 & 干预措施
Open Label Main Arm
Single Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma)
干预措施: 18F-rhPSMA-7.3 (Posluma) (Drug)
结局指标
主要结局
Cancer Detection Rate
时间窗: 24 months
Patients who undergo at least one rhPSMA-7.3 (18F) PET-scan will be analyzed for the primary endpoint. The malignant lesion detectability rate will be summarized using percentage and 95% confidence interval estimates overall and for those who underwent a single scan or both scans. The diagnostic evaluation aims to identify individuals who are most likely to have an isolated local relapse, as they have the most significant potential for achieving long-term disease control through additional local therapy.
次要结局
- Correlation with biopsy(24 months)
- Correlation with other imaging modalities(24 months)
- Response to therapy(24 months)
- Adverse Events(24 hours)