A Phase 2 interventional study of [68Ga]Ga-OncoACP3 in Prostatic Neoplasms and Prostate Cancer, sponsored by Yong He. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Yong He · Phase 2, Interventional, and Diagnostic
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Yong He is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Histologically or cytologically confirmed
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Participants receive a single intravenous injection of 3-5 mCi \[68Ga\]Ga-OncoACP3, followed by PET/CT imaging at about 1 hour post-injection.
Drug: [68Ga]Ga-OncoACP3
\[68Ga\]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.
Also known as: OncoACP3
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.
Time frame: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging
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.
Time frame: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging
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.
Time frame: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging
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.
Time frame: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging
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.
Time frame: Up to 6 months after [68Ga]Ga-OncoACP3 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.
Time frame: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging
Impact on Clinical Treatment Decisions
Proportion of participants whose clinical treatment decisions were changed based on \[68Ga\]Ga-OncoACP3 PET imaging findings.
Time frame: Within 1 month after [68Ga]Ga-OncoACP3 PET imaging
Plan to share: No
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Studies of the drug tested here: Gallium-68
Yong He