64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 1/2 Study of Participants With Biochemical Recurrence of Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The aim of this study is to determine the safety and efficacy of 64Cu-SAR-bisPSMA and determine the ability of 64Cu-SAR-bisPSMA Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following definitive therapy.
详细描述
Participants with biochemical evidence of recurrence of PC were evaluated with 64CU-SAR-bisPSMA PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later, eg. Histopathology/biopsy, conventional imaging, PSA reduction post focal salvage therapy or radiotherapy with no concomitant androgen deprivation therapy. Three independent central readers blinded to the participant number, the time of the PET/CT scan and the results of the conventional methodologies assessed the 64Cu-SAR-bisPSMA PET/CT. Three separate independent readers assessed the results of the conventional methodologies.
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
- •At least 18 years of age.
- •Signed informed consent.
- •Life expectancy ≥ 12 weeks as determined by the Investigator.
- •Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
- •Suspected recurrence of prostate cancer (PC) based on rising Prostate-specific antigen (PSA) after definitive therapy on the basis of:
- •Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or
- •Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition).
- •Negative or equivocal findings for PC on conventional imaging performed as part of standard of care workup within 60 days prior to Day
- •The Eastern Cooperative Oncology performance status 0-
- •Adequate recovery from acute toxic effects of any prior therapy.
- •Estimated Glomerular Filtration Rate of 30 mL/min or higher.
- •Adequate liver function.
- •For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.
排除标准
- •Participants who received other investigational agents within 28 days prior to Day
- •Participants administered any high energy (>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day
- •Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy (e.g. androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist) for PC.
- •Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
- •Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
研究组 & 干预措施
64Cu-SAR-bisPSMA
Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-bisPSMA.
干预措施: 64Cu-SAR-bisPSMA (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: up to 7 days post injection
Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by CTCAE version 5.0
Participant-level Correct Detection Rate (CDR)- Day 0
时间窗: Day 0 (1- 4 hours) post injection
The percentage of TP participants on the Day 0 scan out of all participants with a Day 0 scan.
Participant-level CDR- Day 1
时间窗: Day 1 (24+/-6 Hours) post injection
The percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan.
Region-level Positive Predictive Value (PPV)- Day 0
时间窗: Day 0 (1- 4 hours)
The percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan.
Region-level PPV- Day 1
时间窗: Day 1 (24 +/- 6 hours)
The percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan.
次要结局
- Biodistribution of 64Cu-SAR-bisPSMA- SUVmax(Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours))
- Biodistribution of 64Cu-SAR-bisPSMA- SUVmean(Day 0 (1 -4 hours) and Day 1 (24 +/- 6 hours) post injection)
- Biodistribution of 64Cu-SAR-bisPSMA- SUVr(Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours))
- Participant-level PPV(Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours))
- Participant-level Detection Rate (DR)(Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours))
- Participant-level False Positive Rate (FPR)(Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours))
- Region-level FPR(Day 0 (1-4 hours) and Day 1 (24 +/-6 hours))
- Participant-level Discrepant PET Negativity Rate(Day 0 (1-4 hours) and Day 1 (24 +/-6 hours))
- Participant-level True Negative Rate (TNR)(Day 0 (1-4 hours) and Day 1 (24 +/-6 hours))
- Region-level TNR(Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours))