NCT06056830招募中3 期
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 383
- 试验地点
- 53
- 主要终点
- Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
研究概览
简要总结
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
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.
- •Untreated, histologically confirmed adenocarcinoma of the prostate.
- •High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL).
- •Patients electing to undergo RP with PLND.
排除标准
- •Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day
- •Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
- •Patients with known predominant small cell or neuroendocrine PC.
研究组 & 干预措施
64Cu-SAR-bisPSMA
Experimental
200MBq 64Cu-SAR-bisPSMA.
干预措施: 64Cu-SAR-bisPSMA (Drug)
结局指标
主要结局
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
时间窗: Up to 16 weeks
Independent primary endpoints for Day 1 and Day 2 PET: Co-primary endpoint of sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer within the pelvic lymph nodes compared to the Standard of Truth.
次要结局
- Safety and tolerability of 64Cu-SAR-bisPSMA(Up to 16 weeks)
- Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers(Up to 16 weeks)
- PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs(Up to 16 weeks)
- Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer(Up to 16 weeks)
- Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching(Up to 16 weeks)
研究者
研究点 (53)
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相关资讯
Clarity Pharmaceuticals Secures Large-Scale Copper-64 Manufacturing Agreement with Theragenics for Prostate Cancer Diagnostic- Clarity Pharmaceuticals signed a manufacturing supply agreement with Theragenics for large-scale copper-64 production at their 134,000 square foot facility with 14 cyclotrons near Atlanta, Georgia.
- The agreement supports commercial preparation for 64Cu-SAR-bisPSMA, which has a 12.7-hour half-life offering superior logistics compared to current PSMA PET isotopes with less than 2-hour half-lives.
- Theragenics can produce around 100Ci of copper-64 per day per cyclotron, translating to approximately 2,000 patient doses daily with a 48-hour shelf life.
- This partnership expands Clarity's copper-64 supply network alongside existing agreements with SpectronRx and Nusano, positioning for commercial launch pending FDA approval of ongoing Phase III trials AMPLIFY and CLARIFY.5 months agoClarity Pharmaceuticals' 64Cu-SAR-bisPSMA Evaluated in Head-to-Head Prostate Cancer Imaging Trial- The phase 2 Co-PSMA trial will compare 64Cu-SAR-bisPSMA PET/CT imaging to the standard 68Ga-PSMA-11 PET/CT for detecting prostate cancer recurrence.
- The trial will enroll 50 patients with biochemical recurrence after radical prostatectomy, assessing the detection rate of recurrence sites.
- 64Cu-SAR-bisPSMA, which received FDA fast track designation in August 2024, aims to improve the accuracy of recurrence detection.
- Previous phase 1 data showed favorable safety and efficacy of 64Cu-SAR-bisPSMA, leading to the ongoing phase 3 CLARIFY trial.last yearFDA Grants Fast Track Designation to 64Cu-SAR-bisPSMA for PSMA+ Prostate Cancer Imaging- The FDA granted Fast Track designation to 64Cu-SAR-bisPSMA, a novel PET imaging agent, for detecting prostate-specific membrane antigen (PSMA)-positive prostate cancer lesions with suspected metastases.
- Phase 1 PROPELLER trial data showed a 100% primary prostate cancer detection rate by one reader and 85.7% by another, with greater uptake compared to the standard of care 68Ga-PSMA-11.
- Phase 1/2 COBRA trial results indicated detection rates ranging from 44% to 80% on days 0 and 1, respectively, in patients with biochemical recurrence of prostate cancer.
- 64Cu-SAR-bisPSMA's dual targeting structure and longer half-life enable next-day imaging, potentially detecting smaller lesions with higher tumor uptake and retention.last yearClarity's 64Cu-SAR-bisPSMA Shows Promise in Detecting Prostate Cancer Recurrence in COBRA Trial- Initial results from Clarity Pharmaceuticals' Phase 1/2 COBRA trial demonstrate that 64Cu-SAR-bisPSMA safely and effectively detects prostate cancer lesions in patients with biochemical recurrence who had negative standard-of-care imaging.
- The novel radiopharmaceutical identified lesions in up to 80% of patients on next-day imaging, with the number of detected lesions almost doubling compared to same-day imaging, highlighting a unique benefit of copper-64's longer half-life.
- Clinicians reported they would change treatment plans for approximately 50% of patients based on 64Cu-SAR-bisPSMA scan results, with two-thirds of these patients subsequently receiving focal or systemic therapy.2 years ago