A Study to Evaluate the Diagnostic Performance of ACP3-Targeted PET Imaging in Patients With Primary and Recurrent Prostate Cancer: An Open-Label, Single-Arm, Single-Center Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lesion Detection Rate of [68Ga]Ga-OncoACP3 PET Imaging
研究概览
简要总结
This study aims to evaluate the diagnostic performance of [68Ga]Ga-OncoACP3 PET imaging, which targets prostate acid phosphatase (ACP3), in men with clinically suspected or confirmed high-risk prostate cancer, or suspected recurrence after treatment. The study will assess the ability of this imaging to detect lesions and its diagnostic performance, including sensitivity, specificity, and accuracy. Histopathology and/or clinical follow-up of at least 6 months will be used as the reference standard. Participants will receive a single intravenous injection of [68Ga]Ga-OncoACP3 and undergo a PET/CT scan about 1 hour later. For participants who have already undergone clinically routine PSMA PET imaging, a comparison between the two imaging modalities will be performed. The study will enroll 50 men aged 18 to 90 years. Additionally, the study will explore the correlation between semi-quantitative parameters derived from [68Ga]Ga-OncoACP3 PET imaging and pathological markers (ACP3 expression assessed by immunohistochemistry in tumor tissue), and will evaluate the impact of [68Ga]Ga-OncoACP3 PET imaging on clinical treatment decisions.
详细描述
Background Prostate cancer is the second most common cancer in men worldwide. Accurate diagnosis, staging, and risk stratification are critical for optimal management. PSMA PET imaging has improved prostate cancer detection but has limitations, including heterogeneous PSMA expression leading to false negatives, and physiological uptake in salivary glands, liver, spleen, and intestine that can obscure lesions or cause false-positive findings. ACP3 (prostate acid phosphatase, PAP) is highly and homogeneously expressed in more than 95% of prostate cancer lesions but has low expression in healthy tissues. OncoACP3 is a small-molecule ligand with picomolar affinity for ACP3. Preclinical and early clinical studies suggest that [68Ga]Ga-OncoACP3 PET has favorable biodistribution, low background uptake, and high tumor-to-background ratios, potentially outperforming PSMA PET in certain settings.
Study Objectives Primary objective: To prospectively evaluate the lesion detection rate and diagnostic performance (including sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) of [68Ga]Ga-OncoACP3 PET imaging in men with clinically suspected or confirmed high-risk prostate cancer, or suspected recurrence after treatment.
Secondary objectives: (1) comparison with [68Ga]Ga-PSMA PET imaging in participants who have already undergone clinically routine PSMA PET; (2) correlation of semi-quantitative parameters derived from [68Ga]Ga-OncoACP3 PET imaging with pathological markers (ACP3 expression assessed by immunohistochemistry in tumor tissue); (3) evaluation of the impact of [68Ga]Ga-OncoACP3 PET imaging on clinical treatment decisions.
Study Design This is a prospective, single-arm, single-center, open-label clinical study enrolling 50 male participants aged 18 to 90 years with clinically suspected or confirmed high-risk prostate cancer, or suspected recurrence after treatment. After enrollment and informed consent, participants will undergo [68Ga]Ga-OncoACP3 PET/CT imaging within 1 week. A single intravenous dose of 3-5 mCi [68Ga]Ga-OncoACP3 will be administered, followed by PET/CT imaging at 1 hour post-injection. For participants who have already undergone clinically routine PSMA PET imaging, a comparison between the two imaging modalities will be performed. Image analysis will include visual qualitative assessment and semi-quantitative analysis (e.g., standardized uptake value). The gold standard for diagnosis will be histopathological examination and/or clinical follow-up of at least 6 months. The study will also assess the correlation between semi-quantitative PET parameters and ACP3 expression in tumor tissue, and evaluate the impact of imaging findings on clinical management.
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1. Voluntary participation and signed written informed consent before any study-specific procedures;
- •Male, aged 18 to 90 years;
- •Clinically suspected high-risk, histologically confirmed, or suspected recurrent prostate cancer after treatment;
- •Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study-related procedures;
- •Expected survival time greater than 6 months;
- •Participants' partners agree to use reliable contraceptive measures (such as abstinence, sterilization surgery, oral contraceptives, injectable medroxyprogesterone acetate, or subdermal implants) during the study and for at least 6 months after the last dose of study drug.
排除标准
- •1. Known or suspected allergy to [68Ga]Ga-OncoACP3 injection or any of its excipients;
- •Any severe unstable disease (e.g., severe cardiac, pulmonary, hepatic, or renal insufficiency) that, in the investigator's judgment, makes the participant unsuitable for the study;
- •Inability to complete PET/CT examination, including inability to lie flat, claustrophobia, or radiophobia;
- •Poor compliance or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study;
- •Prior use of a radiopharmaceutical within less than 10 physical half-lives before study drug administration;
- •Currently participating in or planning to participate in any drug or device clinical trial during the study period.
研究组 & 干预措施
[68Ga]Ga-OncoACP3 PET Imaging
Participants receive a single intravenous injection of 3-5 mCi [68Ga]Ga-OncoACP3, followed by PET/CT imaging at about 1 hour post-injection.
干预措施: [68Ga]Ga-OncoACP3 (Drug)
结局指标
主要结局
Lesion Detection Rate of [68Ga]Ga-OncoACP3 PET Imaging
时间窗: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging
Proportion of participants with at least one prostate cancer lesion detected by \[68Ga\]Ga-OncoACP3 PET/CT imaging, using histopathology and/or clinical follow-up of at least 6 months as the reference standard.
Sensitivity of [68Ga]Ga-OncoACP3 PET Imaging
时间窗: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging
Sensitivity of \[68Ga\]Ga-OncoACP3 PET/CT imaging for detecting tumor lesions, using histopathology and/or clinical follow-up of at least 6 months as the reference standard.
Specificity of [68Ga]Ga-OncoACP3 PET Imaging
时间窗: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging
Specificity of \[68Ga\]Ga-OncoACP3 PET/CT imaging for detecting tumor lesions, using histopathology and/or clinical follow-up of at least 6 months as the reference standard.
Accuracy of [68Ga]Ga-OncoACP3 PET Imaging
时间窗: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging
Accuracy of \[68Ga\]Ga-OncoACP3 PET/CT imaging for detecting tumor lesions, using histopathology and/or clinical follow-up of at least 6 months as the reference standard.
次要结局
- Comparison with [68Ga]Ga-PSMA PET Imaging(Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging)
- Correlation Between Semi-Quantitative PET Parameters and ACP3 Expression(Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging)
- Impact on Clinical Treatment Decisions(Within 1 month after [68Ga]Ga-OncoACP3 PET imaging)
研究者
Yong He
Director, Department of Nuclear Medicine, Zhongnan Hospital of Wuhan University
Zhongnan Hospital