Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 17
- 主要终点
- To compare urinary bladder radioactivity observed on piflufolastat (18F) PET and flotufolastat (18F) PET.
研究概览
简要总结
Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy
详细描述
This is a multi-center, prospective intra-patient comparator study of urinary radioactivity (standardized uptake values [SUV]) following both piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET) in patients with low prostate-specific antigen (PSA; ≤0.5 ng/mL) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy (RP).
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
- •Male ≥18 years of age at Visit 1 (Screening).
- •Documented history of localized adenocarcinoma of the prostate with prior curative intent treatment with RP and undetectable PSA post-surgery, experiencing BCR of prostate cancer.
- •At least 6 months must have elapsed after RP.
- •Low PSA BCR defined as PSA ≤0.5 ng/mL.
- •Scheduled by their treating physician to receive a PSMA (18F) PET scan.
- •Written informed consent obtained from the patient and ability for the patient to comply with the requirements of the study.
排除标准
- •Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.
- •Patients who are planned to have an x-ray contrast agent or any other PET radiotracer within 24 hours prior to either PSMA PET scan.
- •Patients who have already received a piflufolastat (18F) PET scan prior to providing informed consent for this study.
- •Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to either of the PSMA PET scans in this study.
- •Patients with known hypersensitivity to the active substance or to any of the excipients of piflufolastat (18F) or flotufolastat (18F).
- •Patients who have previously undergone a cystectomy or have renal failure, or have other conditions that may significantly affect urinary output, as judged by the investigator.
- •Patients who have already received salvage therapy.
研究组 & 干预措施
piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET)
Each patient will be administered a single dose of piflufolastat (18F) on Day 1, followed by a PET scan. At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days, all patients will be administered a single dose of flotufolastat (18F) followed by a PET scan.
干预措施: piflufolastat (18F) (Drug)
piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET)
Each patient will be administered a single dose of piflufolastat (18F) on Day 1, followed by a PET scan. At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days, all patients will be administered a single dose of flotufolastat (18F) followed by a PET scan.
干预措施: flotufolastat (18F) (Drug)
结局指标
主要结局
To compare urinary bladder radioactivity observed on piflufolastat (18F) PET and flotufolastat (18F) PET.
时间窗: Screening, piflufolastat (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days
Difference in urinary bladder mean SUV (SUVmean) between piflufolastat (18F) and flotufolastat (18F).
次要结局
- To assess the following for piflufolastat (18F) PET and flotufolastat (18F) PET: Detection rates; Detection rates stratified by PSA level; Prostate bed detection rates: local recurrences by subregion; Pelvic lymph node (PLN) detection rates(Screening, piflufolastat (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days)