2023-507111-35-00招募中2 期
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.
Curasight A/S, Curasight A/S9 个研究点 分布在 3 个国家目标入组 140 人开始时间: 2024年4月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 9
- 主要终点
- Part 1: SUVmax at 30, 60, and 120-min. post-injection
研究概览
简要总结
Part 1: To assess the robustness of SUVmax measurements obtained at a 64Cu DOTA-AE105 dose of 100 MBq, 150 MBq, and 200 MBq in patients with untreated, localised PCa. Part 2: To determine the disciminative properties of uPAR PET (SUVmax) for the classification of ISUP grades 1 form 2 and ISUP grades 2 from 3 in patients with untreated, localised PCa.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathology-verified prostate adenocarcinoma
- •Pathology material available for central review
- •International Society of Urological Pathology (ISUP) grade 1 to 3
- •Localised prostate cancer. a. No clinical suspicion of prostate cancer outside the prostatic bed at the time of enrolment into the trial; and b. If N- and M- staging has been performed (at the initial staging or at any later time points), the results must be N0 and M
- •Prostate biopsy within 1 to 6 months prior to the first planned day of injection of 64Cu-DOTA-AE105 (patients with a biopsy within the last month are excluded to avoid possible inflammation artefacts on the PET scan) a. The biopsy can be part of the primary staging, a confir matory biopsy, or serial biopsy conducted as part of an AS or watchful waiting program. b. 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
结局指标
主要结局
Part 1: SUVmax at 30, 60, and 120-min. post-injection
Part 1: SUVmax at 30, 60, and 120-min. post-injection
Part 2: SUVmax in PET acquisitions at 60 min p.i. of 200 MBq.
Part 2: SUVmax in PET acquisitions at 60 min p.i. of 200 MBq.
次要结局
- Part 1: SUVmax in PET acquisitions at 60 min post-injection on days 1 and 8.
- Part 1: Evaluate PK parameters Cmax, Tmax, AUC, Vd, clearance, T1/2 from periodic radioactive counts from whole blood plus the elimination of 64Cu DOTA AE105 into a pooled urine sample to determine activity per mL which will be extrapolated to the mass dose (pg/mL) of IMP.
- Part 1: SUVmax in PET acquisitions at 30, 60 and 120 min p.i.
- Part 1: Tumour visibility (numerical rating scale [NRS], 0–2 rating) in PET acquisitions at 30, 60 and 120 min p.i.
- Part 1: a) SUVmax centred around 60 min p.i. with reconstructions of 3-, 5-, 10-, 20-, 30-, and 40-min frame durations in the 200 MBq cohort. b) Tumour visibility (NRS 0–2 rating) centred around 60 min p.i. with reconstructions of 3-, 5-, 10-, 20-, 30, and 40-min frame durations in the 200 MBq cohort.
- Part 2: SUVmax in PET acquisitions at 60 min p.i.
- Part 2: Tumour visibility (NRS 0–2 rating) in PET acquisitions at 60 min p.i.
研究者
info@curasight.com
Scientific
Curasight A/S
研究点 (9)
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