An interventional study of standard-of-care imaging (PSMA/FDG PET/CT), ACP3 PET/CT in Prostate Cancer (Diagnosis), sponsored by Guilin Medical University, China. Recruiting at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Guilin Medical University, China · Not applicable, Interventional, and Diagnostic
The objective of the study is to construct a noninvasive approach ACP3 targeted PET/CT to detect tumor lesions in patients with prostate cancer and to compare with PSMA/FDG PET/CT.
ACP3 targeting PET radiotracer is promising as an excellent imaging agent applicable to prostate cancer. In this research, subjects with prostate cancer or highly suspected recurrence detection underwent contemporaneous ACP3 PET/CT and standard-of-care imaging (PSMA/FDG PET/CT) either for an initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care imaging and 68Ga-PSMA PET/CT were recorded by visual interpretation. The diagnostic accuracy of ACP3 PET/CT was calculated and compared to standard-of-care imaging.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Guilin Medical University, China is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Each subject receives a single intravenous injection of radiolabeld ACP3 and undergoes PET/CT imaging within the specified time.
Diagnostic Test: standard-of-care imaging (PSMA/FDG PET/CT), ACP3 PET/CT
Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceutical (PSMA/FDG) and ACP3, and undergoes PET/CT imaging within the specified time.
Diagnostic efficacy
The sensitivity, specificity, and accuracy of standard-of-care imaging (PSMA/FDG PET/CT) and ACP3 PET/CT were calculated and compared to evaluate the diagnostic accuracy.
Time frame: 3 year
Number of lesions
The numbers of positive primary and metastatic lesions of standard-of-care imaging (PSMA/FDG PET/CT) and ACP3 PET/CT were recorded by visual interpretation.
Time frame: 3 year
SUV
Standardized uptake value (SUV) of standard-of-care imaging (PSMA/FDG PET/CT) and ACP3 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.
Time frame: 3 year
Plan to share: No
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Guilin Medical University, China