Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology
研究概览
简要总结
The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.
详细描述
This is a multi-centre, blinded review, dose ranging, non-randomized study of 64Cu-SAR-bisPSMA administered to participants with confirmed Prostate Cancer. 30 eligible participants will be allocated (1:1:3) to 1 of 3 dosing cohorts to be administered with 64Cu-SAR-bisPSMA 100 MBq, 150 MBq or 200 MBq. PET/CT scan images will be sent to blinded central readers to assess the capacity of 64Cu-SAR-bisPSMA to detect primary Prostate Cancer, to assess image quality of the various dose cohorts, and to assess the PET/CT scan features of 64Cu-SAR-bisPSMA in comparison standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Signed informed consent;
- •≥18 years of age;
- •Life expectancy >3 months;
- •Confirmation of Prostate Cancer by histopathology and planned radical prostatectomy;
- •Have ≥1 of the following intermediate- to high-risk features:
- •PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment;
- •International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above;
- •Clinical stage greater than or equal to T2b;
- •Participants must have adequate renal function;
- •Sexually active participants who have female partners of childbearing potential: Partner and/or participant must agree to use an acceptable form of contraception. Further participants must refrain from donating sperm;
- •A 68Ga-PSMA-11 PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SAR-bisPSMA.
排除标准
- •Prior prostatectomy or any other treatment for Prostate Cancer, including Androgen Deprivation Therapy and radiation therapy;
- •Previous treatment with PSMA-targeted therapy within 3 months prior to enrolment, and administration of other investigational agents within 4 weeks prior to entering the study (except 68Ga-PSMA-11);
- •Known hypersensitivity to the components of 64Cu-SAR-bisPSMA;
- •Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;
- •Any serious medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;
- •Patients unwilling or unable to comply with protocol or with a history of noncompliance or inability to grant informed consent.
研究组 & 干预措施
Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA
Participants will receive a single administration, a bolus injection of 150 MBq 64Cu-SAR-bisPSMA.
干预措施: 64Cu-SAR-bisPSMA (Drug)
Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA
Participants will receive a single administration, a bolus injection of 100 MBq 64Cu-SAR-bisPSMA.
干预措施: 64Cu-SAR-bisPSMA (Drug)
Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA
Participants will receive a single administration, a bolus injection of 200 MBq 64Cu-SAR-bisPSMA.
干预措施: 64Cu-SAR-bisPSMA (Drug)
结局指标
主要结局
Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology
时间窗: 11 weeks
Efficacy will be measured by the proportion of 64Cu-SAR-bisPSMA PET/CT scans assessed as True Positive or False Negative for primary Prostate Cancer, as confirmed by histopathology.
Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5
时间窗: 11 weeks
Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.
次要结局
- Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq).(11 weeks)