An Open-label, Two-part, Phase 2 Clinical Trial to Investigate the Safety and Diagnostic Performance of uPAR PET Imaging for Non-invasive Classification of ISUP Grades Among Patients With Localised, Untreated Prostate Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- Part 1: Standard uptake value (SUV) max at 30, 60, and 120 minutes post-injection (p.i.) - robustness
研究概览
简要总结
The goal of this clinical trial is to test if the experimental agent accurately determines the aggressiveness of prostate cancer (biopsy-verified ISUP grade). The aim is that the diagnostic PET imaging agent may be used as an alternative or supplement to biopsies in the monitoring of patients with low-risk prostate cancer in active surveillance.
Patients diagnosed with untreated, low-grade, localized prostate cancer may participate in the trial. The experimental diagnostic agent 64Cu-DOTA-AE105 is a radiopharmaceutical which is injected into the veins and binds to uPAR expressing cells in the tumour which can then be visualized in a PET scanner.
The main question the trial aims to answer is: Can the test drug be used alone or as a supplement to repeated biopsies to accurately assess the aggressiveness of prostate cancer?
The trial is divided in 2 parts:
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Participants in the first part will receive 2 injections of test drug on 2 different days.
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The first day the participant will receive an injection of the test drug and then be asked to lie down in the PET/CT scanner so that images of the prostate can be taken. Before and after the injection/scanning procedure the participant will have tests done. These tests will include evaluation of health status, measurement of heart function by ECG plus blood and urine samples.
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After 8 days the procedures, including injection of test drug and scanning, will be repeated.
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Participants in the second part of the trial will only have 1 injection of the test drug and subsequent PET/CT scanning. Like in Part 1 of the trial, tests will be done before and after the injection/ scanning procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Pathology-verified prostate adenocarcinoma
- •International Society of Urological Pathology (ISUP) grade 1 to 3
- •Localised prostate cancer (N0 and M0 status) (only required for ISUP 3 patients)
- •Newly diagnosed patients: Staging must be performed within 6 months from enrolment into the trial.
- •Active surveillance: N0/M0 at the time of diagnosis and no clinical suspicion of prostate cancer outside the prostatic bed at the time of enrolment into the trial.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Prostate biopsy within 1 to 6 months (patients with a biopsy within the last month are excluded to avoid possible inflammation artefacts on the PET scan)
- •The biopsy can be part of the primary staging, a confirmatory biopsy, or serial biopsy as part of an AS.
- •At least 1 core must be MRI-guided.
排除标准
- •Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy)
- •Chronic prostatitis (any signs or symptoms of chronic bacterial prostatitis or chronic pelvic prostatitis and pain syndrome, or known diagnosis of asymptomatic inflammatory prostatitis)
- •Acute infections within the prostatic bed or lower urinary tract infections
- •Participants have inadequate bone marrow, kidney, liver, heart, or lung function:
研究组 & 干预措施
100 MBq 64Cu-DOTA-AE105
For Part 1 of the trial, 9 patients will receive 100 MBq 64Cu-DOTA-AE105 Day 1 and Day 8
干预措施: 64Cu-DOTA-AE105 (Drug)
150 MBq 64Cu-DOTA-AE105
For Part 1 of the trial, 9 patients will receive 150 MBq 64Cu-DOTA-AE105 Day 1 and Day 8
干预措施: 64Cu-DOTA-AE105 (Drug)
200 MBq 64Cu-DOTA-AE105
For Part 1 of the trial, 9 patients will receive 200 MBq 64Cu-DOTA-AE105 Day 1 and Day 8.
For Part 2 of the trial, additional 141 patients will receive 200 Mbq 64Cu-DOTA-AE105
干预措施: 64Cu-DOTA-AE105 (Drug)
结局指标
主要结局
Part 1: Standard uptake value (SUV) max at 30, 60, and 120 minutes post-injection (p.i.) - robustness
时间窗: Day 1
Part 1: mean of 3 independent readings of SUVmax at positron emission tomography (PET) aquisition times 30, 60, and 120 minutes p.1
Part 2: SUVmax at 60 minutes p.i.
时间窗: 60 minutes post-injection
Part 2: mean of 3 independent readings of SUVmax at PET aquisition time 60 minutes p.i.
次要结局
- Part 2: SUVmax variation between local and central readers(60 minutes post-injection)
- Part 2: Tumour visibility in PET acquisitions(60 minutes post injection)
- Part 2: Inter-reader variability of SUVmax(60 minutes post injection)
- Part 2: Inter-reader tumour visibility in PET acquisitions(60 minutes post injection)
- Part 1:Volume of distribution (Vd) from periodic radioactive counts from whole blood(Day 1)
- Part 1:Tmax from periodic radioactive counts from whole blood(Day 1)
- Part 1: Area under curve (AUC) from periodic radioactive counts from whole blood(Day 1)
- Part 1: Inter-reader variation in tumour visibility(Day 1)
- Part 1: SUVmax in PET acquisitions at 60 minutes p.i.(Day 1 and Day 8)
- Part 1: Cmax from periodic radioactive counts from whole blood(Day 1)
- Part 1:Clearance from periodic radioactive counts from whole blood(Day 1)
- Part 1: Elimination of 64Cu-DOTA-AE105 into a pooled urine sample(Day 1)
- Part 1: Inter-reader variability of SUVmax(Day 1)
- Part 1:Intra-reader variability of SUVmax(Day 1)
- Part 1: Intra-reader variation in tumour visibility(Day 1)
- Part 1: SUVmax using different acquisition durations(Day 1)
- Part 1: Variation in tumour visibility using different acquisition durations in the 200 MBq cohort(Day 1)
- Part 2: Intra-reader variability of SUVmax(60 minutes post injection)
- Part 2: Intra-reader tumour visibility in PET acquisitions(60 minutes post injection)