NCT07568756尚未招募2 期
Utilization of Flotufolastat 18F PET for Post-Focal Therapy Prostate Cancer Evaluation
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Flotufolastat F18 PET findings
研究概览
简要总结
This is a phase II single arm, open-label clinical trial determining diagnostic accuracy of Flotufolastat F18 PET in subjects with prostate adenocarcinoma. These are subjects who have not previously received treatment for prostate cancer.
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
- •Age 18 years or greater at time of consent
- •Prostate adenocarcinoma (no other histologic subtypes allowed)
- •Prostate Cancer planned to be treated by focal therapy (e.g. cryotherapy, HIFU, or NanoKnife)
- •Multiparametric-MRI imaging planned
- •Planned pre- and post- treatment MRI-fusion biopsy
排除标准
- •Prior treatment for any prostate malignancy (e.g. radiation, focal therapy, or systemic therapy)
- •Genomic classifiers (e.g. Decipher) signifying intermediate or high-risk disease
- •High-risk prostate cancer (diagnosed by biopsy)
- •Bilateral prostatic lobe disease
研究组 & 干预措施
Post-Focal Therapy Flotufolastat F18PET
Experimental
Post-Focal Therapy Flotufolastat F18 PET
干预措施: Flotufolastat F18 PET (Diagnostic Test)
结局指标
主要结局
Flotufolastat F18 PET findings
时间窗: 5 years
Compare Flotufolastat F18 PET findings to mpMRI and MRI-fusion biopsy results to determine successful treatment by focal therapy.
次要结局
- Changes in Circulating Tumor Deoxyribonucleic acid (ctDNA) levels(5 years)
- Changes in PSA levels(5 years)
- Change in genomic assay scores(5 years)
研究者
Michael Daneshvar
Assistant Professor of Clinical Urology
University of California, Irvine
研究点 (1)
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