NCT06970847进行中（未招募）3 期
64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
- 试验地点
- 24
- 主要终点
- Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
研究概览
简要总结
The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
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 ≥ 6 months as determined by the Investigator.
- •Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
- •Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2).
- •PSA level after definitive therapy:
- •Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or
- •Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition).
- •Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
- •An Eastern Cooperative Oncology performance status of 0-2.
排除标准
- •Participants who received investigational agent within 5 biological half-lives prior to Day
- •Participants administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day
- •Participants with known predominant small cell or neuroendocrine PC.
- •Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy and/or salvage therapy with radiation).
- •Ongoing treatment or treatment within 6 months of Day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for PC.
- •Participants for whom there is an intent to initiate a prohibited medication(s)/treatment(s) (refer to Section 7.3) during the course of the participant's involvement in the study.
- •Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
- •Any serious medical condition or extenuating circumstance (including receiving the investigational product or not capable of having a PET scan) which the investigator feels may interfere with the procedures or evaluations of the study.
研究组 & 干预措施
64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA.
Experimental
干预措施: 64Cu-SAR-bisPSMA (Drug)
结局指标
主要结局
Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
时间窗: Up to 52 Weeks
Co-primary endpoints of participant-level CDR and region level PPV assessed independently for Day 1 and Day 2: * Participant-level CDR, defined as the proportion of TP participants scan out of all participants * Region-level PPV, defined as the proportion of TP regions out of all positive regions.
次要结局
- To investigate the safety and tolerability of 64-CuSAR-bisPSMA(Up to 52 Weeks)
- To assess the participants-level PPV of 64Cu-SAR-bisPSMA PET/CT(Up to 52 Weeks)
- To assess the participant-level DR of 64Cu-SAR-bisPSMA PET/CT(Up to 52 Weeks)
- To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline(Up to 52 Weeks)
- To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT(Up to 52 Weeks)
- To evaluate the consistency among readers and the reproducibility of the 64Cu-SAR-bisPSMA PET/CT readings(Up to 52 Weeks)
研究者
研究点 (24)
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