64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of Participants With PSMA-negative Biochemical Recurrence of Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 8
- 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-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with prostate-specific membrane antigen (PSMA)-negative biochemical recurrence of prostate cancer following definitive therapy.
详细描述
Participants with biochemical evidence of recurrence of prostate cancer (PC) were evaluated with 64Cu-SAR-BBN PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later (e.g., histopathology/biopsy, conventional imaging, prostate specific antigen [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-BBN 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 PC based on rising 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 (1) approved PSMA PET and (2) anatomical imaging (CT and/or magnetic resonance imaging) and (3) if available, any other conventional imaging performed as part of routine standard of care imaging 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.
- •Participants who are known to require prohibited treatment (e.g., initiation of androgen-deprivation therapy due to rapidly rising PSA) before the 64Cu-SAR-BBN PET/CT results can be verified via histopathology or follow-up imaging.
- •Known or expected hypersensitivity to 64Cu-SAR-BBN 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-BBN
Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-BBN.
干预措施: 64Cu-SAR-BBN (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 Common Terminology Criteria for Adverse Events (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 true positive (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) post injection
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) post injection
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-BBN - SUVmean - Day 0(Day 0 (1-4 hours) post injection)
- Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1(Day 1 (24 +/- 6 hours) post injection)
- Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0(Day 0 (1-4 hours) post injection)
- Biodistribution of 64Cu-SAR-BBN - SUVr - Day 0(Day 0 (1-4 hours) post injection)
- Participant-level False Positive Rate (FPR)(Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection)
- Participant-level Discrepant PET Negativity Rate(Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection)
- Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1(Day 1 (24 +/- 6 hours) post injection)
- Biodistribution of 64Cu-SAR-BBN - SUVr - Day 1(Day 1 (24 +/- 6 hours) post injection)
- Participant-level PPV(Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection)
- Participant-level Detection Rate (DR)(Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection)
- Region-level FPR(Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection)
- Participant-level True Negative Rate (TNR)(Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection)
- Region-level TNR(Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection)