[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656881":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":41,"studyPopulation":33,"armGroups":42,"interventions":49,"overallOfficials":33,"centralContacts":57,"locations":63,"responsibleParty":79,"collaborators":33,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":33,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":33,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":108,"whyStopped":33,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Zhongnan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":33},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"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\u002FCT imaging, using histopathology and\u002For clinical follow-up of at least 6 months as the reference standard.","Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging",{"measure":14,"description":15,"timeFrame":12},"Sensitivity of [68Ga]Ga-OncoACP3 PET Imaging","Sensitivity of \\[68Ga\\]Ga-OncoACP3 PET\u002FCT imaging for detecting tumor lesions, using histopathology and\u002For clinical follow-up of at least 6 months as the reference standard.",{"measure":17,"description":18,"timeFrame":12},"Specificity of [68Ga]Ga-OncoACP3 PET Imaging","Specificity of \\[68Ga\\]Ga-OncoACP3 PET\u002FCT imaging for detecting tumor lesions, using histopathology and\u002For clinical follow-up of at least 6 months as the reference standard.",{"measure":20,"description":21,"timeFrame":12},"Accuracy of [68Ga]Ga-OncoACP3 PET Imaging","Accuracy of \\[68Ga\\]Ga-OncoACP3 PET\u002FCT imaging for detecting tumor lesions, using histopathology and\u002For clinical follow-up of at least 6 months as the reference standard.",[23,26,29],{"measure":24,"description":25,"timeFrame":12},"Comparison with [68Ga]Ga-PSMA PET Imaging","Comparison of lesion detection rate and diagnostic performance between \\[68Ga\\]Ga-OncoACP3 PET\u002FCT and \\[68Ga\\]Ga-PSMA PET\u002FCT in participants who have undergone clinically routine PSMA PET imaging.",{"measure":27,"description":28,"timeFrame":12},"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.",{"measure":30,"description":31,"timeFrame":32},"Impact on Clinical Treatment Decisions","Proportion of participants whose clinical treatment decisions were changed based on \\[68Ga\\]Ga-OncoACP3 PET imaging findings.","Within 1 month after [68Ga]Ga-OncoACP3 PET imaging",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"NA","SINGLE_GROUP","All participants will receive a single intravenous injection of \\[68Ga\\]Ga-OncoACP3 followed by PET\u002FCT imaging at about 1 hour post-injection. For participants who have already undergone clinically routine PSMA PET imaging, a head-to-head comparison between the two imaging modalities will be performed. No randomization or blinding is applied.","DIAGNOSTIC",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE","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.\n\nStudy 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.\n\nSecondary 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.\n\nStudy 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\u002FCT imaging within 1 week. A single intravenous dose of 3-5 mCi \\[68Ga\\]Ga-OncoACP3 will be administered, followed by PET\u002FCT 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\u002For 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.",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"[68Ga]Ga-OncoACP3 PET Imaging","EXPERIMENTAL","Participants receive a single intravenous injection of 3-5 mCi \\[68Ga\\]Ga-OncoACP3, followed by PET\u002FCT imaging at about 1 hour post-injection.",[48],"Drug: [68Ga]Ga-OncoACP3",[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"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\u002FCT imaging is performed at about 1 hour post-injection.",[44],[56],"OncoACP3",[58],{"name":59,"role":60,"phone":61,"phoneExt":33,"email":62},"Yong He, MD, PhD","CONTACT","027-67812837","heyong@whu.edu.cn",[64],{"facility":65,"status":33,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Zhongnan Hospital of Wuhan University","Wuhan","Hubei","430071","China","CN",{"type":72,"coordinates":73},"Point",[74,75],114.26667,30.58333,{"lat":75,"lon":74},[78],{"name":59,"role":60,"phone":61,"phoneExt":33,"email":62},{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Yong He","Director, Department of Nuclear Medicine, Zhongnan Hospital of Wuhan University","100656881","phase-2-diagnostic-performance-of-acp3-targeted-pet-imaging-in-patients-with-primary-and-recurrent-prostate-cancer-an-open-label-single-arm-single-center-study-100656881",false,"NCT07830212","Diagnostic Performance of ACP3-Targeted PET Imaging in Patients With Primary and Recurrent Prostate Cancer: An Open-Label, Single-Arm, Single-Center Study","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","Inclusion Criteria:\n\n* Voluntary participation and signed written informed consent before any study-specific procedures;\n* Male, aged 18 to 90 years;\n* Clinically suspected high-risk, histologically confirmed, or suspected recurrent prostate cancer after treatment;\n* Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study-related procedures;\n* Expected survival time greater than 6 months;\n* 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.\n\nExclusion Criteria:\n\n* Known or suspected allergy to \\[68Ga\\]Ga-OncoACP3 injection or any of its excipients;\n* 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;\n* Inability to complete PET\u002FCT examination, including inability to lie flat, claustrophobia, or radiophobia;\n* Poor compliance or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study;\n* Prior use of a radiopharmaceutical within less than 10 physical half-lives before study drug administration;\n* Currently participating in or planning to participate in any drug or device clinical trial during the study period.","MALE","18 Years","90 Years",{"count":94,"type":95},50,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","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\u002For 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\u002FCT 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.",[101,102],"Prostatic Neoplasms","Prostate Cancer",[104,105,106,107],"Prostate acid phosphatase","[68Ga]Ga-OncoACP3 PET\u002FCT","Diagnostic performance","Prostate cancer","NOT_YET_RECRUITING","2026-09-21",{"date":111,"type":112},"2026-09-23","ACTUAL",{"date":114,"type":95},"2026-10",{"date":116,"type":95},"2028-06",{"name":81,"class":6},1]