Phase II/III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging for the Detection of PSMA Positive Tumors Using Histopathology as a Standard of Truth
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- Patient-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity
研究概览
简要总结
The purpose of this study was to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) were used for the histopathology assessments.
详细描述
This was a multi-center, single-arm, open-label prospective study to evaluate the diagnostic performance of vidoflufolastat (18F) as a positron emission tomography (PET) imaging agent for detection and localization of prostate specific membrane antigen (PSMA) positive tumors, using histopathology as standard of truth (SoT). in newly diagnosed high-risk prostate cancer (PCa) patients.
A total of 195 participants were enrolled to ensure that at least 156 participants were evaluable for the co-primary endpoints. Surgery was performed after vidoflufolastat (18F) positron emission tomography/computerized tomography (PET/CT) scan.
The co-primary endpoints of patient-level sensitivity and region-level specificity were assessed by comparing the central reading results of the vidoflufolastat (18F) PET/CT scan to the local histopathology results in the dissected tissue specimens, i.e. both the primary tumor and the dissected Pelvic Lymph Nodes (PLNs).
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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Untreated high risk biopsy-proven PCa patients according to D'Amico classification (Stage ≥ T2c or PSA level >20ng/ml or Gleason score ≥8) (D'Amico et al 1998)
- •Scheduled or planned radical prostatectomy and extended pelvic lymph node resection up to 6 weeks after the investigational PET/CT scan followed by histopathology assessment
- •ECOG performance status 0-2
- •Signed informed consent must be obtained prior to participation in the study
- •Participants must be adults ≥ 18 years of age
排除标准
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
- •Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation, including, but not limited to, current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, need of indwelling/condom catheters, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, and COVID-
- •Known allergy, hypersensitivity, or intolerance to [18F]CTT1057
- •Prior and current use of PSMA targeted therapies
- •Prior and current treatment with any ADT (first or second generation), including LHRH analogues (agonists or antagonists)
- •Any 5-alpha reductase inhibitors within 30 days before screening
- •Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
- •Patients with incidental PCa after transurethral resection
- •Use of other investigational drugs within 30 days before screening
研究组 & 干预措施
PET/CT imaging with [18F]CTT1057
All eligible participants will be enrolled to receive [18F]CTT1057 imaging agent on Day 1 and have PET/CT scan
干预措施: [18F]CTT1057 (Drug)
结局指标
主要结局
Patient-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity
时间窗: vidoflufolastat (18F)7 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan
Sensitivity of vidoflufolastat (18F) Positron Emission Tomography (PET) imaging, considering Prostate Specific Membrane Antigen (PSMA) positive patients as those who show at least one pathological vidoflufolastat (18F) uptake either in the primary tumor and/or metastatic Pelvic Lymph Node (PLN) regions, with anatomically localized correspondence with the Standard of Truth (SoT).
Region-level Specificity of Vidoflufolastat (18F) - % Specificity
时间窗: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan
Specificity of vidoflufolastat (18F) PET imaging, defined as proportion of PLN regions that test negative for lymph nodes on vidoflufolastat (18F) among those that are lymph node negative on the SoT.
次要结局
- Patient-level Specificity of Vidoflufolastat (18F) - % Specificity(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Patient-level Positive Predictive Value of Vidoflufolastat (18F)(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Patient-level Negative Predictive Value of Vidoflufolastat (18F)(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Patient-level Accuracy of Vidoflufolastat (18F)(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Region-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Region-level Positive Predictive Value of Vidoflufolastat (18F)(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Region-level Negative Predictive Value of Vidoflufolastat (18F)(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Region-level Accuracy of Vidoflufolastat (18F)(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Region-level Sensitivity of Vidoflufolastat (18F) Scan With Standard of Truth Excluding Pelvic Lymph Node (PLN) Metastasis < 2 mm(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Detection of Distant Metastasis of Vidoflufolastat (18F) Scan - Participants With at Least One Distant Metastatic Lesion (%)(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Overview of Adverse Events(Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.)
- Vidoflufolastat (18F) Scan Inter-reader Variability - %(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Vidoflufolastat (18F) Scan Inter-reader Variability - Number of Scans Agreed(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Vidoflufolastat (18F) Scan Intra-reader Variability(vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan)
- Observed Maximum Blood Concentration (Cmax) of Vidoflufolastat (18F)(Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection))
- Time of Maximum Observed Blood Concentration Occurrence (Tmax) of Vidoflufolastat (18F)(Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection))
- Area Under the Vidoflufolastat (18F) Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)(Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection))
- Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of Vidoflufolastat (18F)(Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post infusion))
- Half-Life Lambda z of Vidoflufolastat (18F)(Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection))
- Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of Vidoflufolastat (18F)(Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection))
- Urinary Excretion of Radioactivity Expressed as a Percentage of Injected Activity (%IA) of Vidoflufolastat (18F)(Day 1 (pre-injection/0 hour, 0 hour (injection) - T (image acquisition starting time), T (image acquisition starting time) to 3 hours, 3 hours to 5 hours post imaging))
- Total Systemic Clearance for Intravenous Administration (CL) of Vidoflufolastat (18F)(Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection))