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.
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;
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;
Single group
[68Ga]Ga-OncoACP3
Drug\[68Ga\]Ga-OncoACP3 is a small-molecule PET imaging agent targeting ACP3 (prostate acid phosphatase). It is radiolabeled with Gallium-68 and administered as a single intravenous dose of 3-5 mCi. PET/CT imaging is performed at about 1 hour post-injection.
Lesion Detection Rate of [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
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
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
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.
Comparison with [68Ga]Ga-PSMA PET Imaging
Comparison of lesion detection rate and diagnostic performance between \[68Ga\]Ga-OncoACP3 PET/CT and \[68Ga\]Ga-PSMA PET/CT in participants who have undergone clinically routine PSMA PET imaging.
Correlation Between Semi-Quantitative PET Parameters and ACP3 Expression
Correlation between semi-quantitative parameters (e.g., standardized uptake value) derived from \[68Ga\]Ga-OncoACP3 PET imaging and ACP3 expression assessed by immunohistochemistry in tumor tissue.
Impact on Clinical Treatment Decisions
Proportion of participants whose clinical treatment decisions were changed based on \[68Ga\]Ga-OncoACP3 PET imaging findings.
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Yong He
Lead sponsor
Zhongnan Hospital
Sponsor institution
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