An Early Phase 1 interventional study of RET-targeted PET/CT molecular imaging and PSMA-targeted PET/CT imaging in Prostate Adenocarcinoma With Focal Neuroendocrine Differentiation and Prostate Cancer, sponsored by Xiangya Hospital of Central South University. Active, not recruiting at 1 site in China. Open to male participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Xiangya Hospital of Central South University · Early Phase 1, Interventional, and Diagnostic
The goal of this observational diagnostic imaging study is to evaluate the value of RET-targeted PET/CT molecular imaging in diagnosing neuroendocrine prostate cancer (NEPC) and in assessing disease activity, treatment response, and prognosis. The study population consists of men aged 45-80 years, including approximately 40 patients with suspected or confirmed NEPC (positive group) and approximately 10 patients with conventional prostatic adenocarcinoma (negative control group).
The main questions it aims to answer are:
Can RET-targeted PET/CT imaging accurately diagnose neuroendocrine prostate cancer, using pathology as the gold standard? Compared with PSMA PET/CT, multiparametric MRI (mpMRI), and serum markers, does RET-targeted PET/CT provide better diagnostic performance (sensitivity, specificity, positive and negative predictive values)? Is the level of RET tracer uptake in lesions associated with disease progression and prognosis, and can it be used for early assessment of treatment response? Researchers will compare RET-PET/CT imaging results against pathology (the primary reference standard), PSMA PET/CT, conventional contrast-enhanced MRI, and serum markers to determine the diagnostic advantage of RET-targeted imaging.
Participants will:
Sign a written informed consent form; Undergo whole-body PET/CT (and if needed, PET/MRI) imaging with RET- and PSMA-targeted tracers (approximately 0.15 mCi/kg injected intravenously; if a repeat scan is needed due to disease changes, it will be performed at least 1 week apart); Have blood pressure, pulse, respiration, and temperature measured before and after imaging, and liver/kidney function tests and routine blood and urine tests performed one day before and after imaging; Undergo multiparametric MRI (mpMRI); Be followed up, with any clinical symptoms or signs of discomfort during and up to two weeks after imaging recorded in detail.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 50 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
Patients with suspected or confirmed neuroendocrine prostate cancer (NEPC) will undergo whole-body PET/CT imaging with a RET-targeted tracer and a PSMA-targeted tracer (approximately 0.15 mCi/kg injected intravenously). Imaging findings will be compared with pathology (the gold standard), serum neuroendocrine markers, and clinical follow-up to evaluate diagnostic performance, treatment response, and prognosis.
Diagnostic Test: RET-targeted PET/CT molecular imaging · Diagnostic Test: PSMA-targeted PET/CT imaging
Patients with conventional prostatic adenocarcinoma (control group) will undergo the same imaging procedures as the NEPC group: whole-body PET/CT (or PET/MRI) with a RET-targeted tracer and a PSMA-targeted tracer (approximately 0.15 mCi/kg intravenously), plus multiparametric MRI (mpMRI), to serve as the negative control for evaluating the specificity of RET-targeted imaging.
Diagnostic Test: RET-targeted PET/CT molecular imaging · Diagnostic Test: PSMA-targeted PET/CT imaging
Participants receive an intravenous injection of a RET-targeted PET tracer (approximately 0.15 mCi/kg, nanomolar tracer dose, radiochemical purity \>95%) prepared and quality-controlled at the investigators' PET center. After resting in a dark room for 5-10 or 45-60 minutes and voiding, whole-body PET/CT (or PET/MRI for head and spine) imaging is performed with an emission scan time of 10-20 minutes. PET images are reconstructed by OSEM. Two experienced nuclear medicine physicians review the images; a lesion with tracer uptake higher than surrounding or contralateral normal tissue is considered positive, and SUVmax, SUVmean, and lesion size are measured by ROI analysis. If disease changes require a repeat scan, it is performed at least 1 week apart.
Participants undergo whole-body PET/CT (or PET/MRI) imaging with a PSMA-targeted tracer (approximately 0.15 mCi/kg injected intravenously) using the same scanner, protocol, image reconstruction, and image analysis procedures as the RET-targeted imaging. PSMA imaging serves as the comparator to evaluate the diagnostic performance of RET-targeted imaging.
Diagnostic accuracy of RET-targeted PET/CT for neuroendocrine prostate cancer (NEPC)
The diagnostic performance of RET-targeted PET/CT for NEPC will be evaluated against pathology (the gold standard, based on biopsy or surgical specimen with neuroendocrine marker immunohistochemistry: SYP/CHGA/NSE). Diagnostic accuracy parameters, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), will be calculated.
Time frame: At the time of imaging, with pathology confirmation within approximately 1 month after imaging
Comparison of diagnostic performance between RET-PET/CT and PSMA PET/CT
Sensitivity, specificity, PPV, and NPV of RET-targeted PET/CT will be compared with those of PSMA PET/CT, and serum neuroendocrine markers to determine the diagnostic advantage of RET-targeted imaging.
Time frame: At the time of imaging
Semi-quantitative tracer uptake (SUVmax and SUVmean) of lesions on RET-targeted PET/CT
The region of interest (ROI) with the highest tracer uptake in each lesion will be delineated, and SUVmax, SUVmean, and lesion size will be measured and compared between groups using independent-samples and paired t-tests.
Time frame: At the time of imaging
Correlation between lesion SUVmax on RET-targeted PET/CT and disease progression
The correlation between the semi-quantitative RET tracer uptake of lesions, measured as SUVmax (unitless ratio) by region-of-interest analysis on RET-targeted PET/CT, and disease progression will be assessed. Disease progression will be determined by clinical evaluation and conventional imaging (PSMA PET/CT, mpMRI) according to clinical criteria, and progression-free survival will be recorded in months. Multivariable analysis (e.g., Cox proportional hazards regression) will be used to evaluate the relationship between baseline SUVmax and time to disease progression or death.
Time frame: Up to 5 years after enrollment
Value of RET-targeted PET/CT for early assessment of treatment response
Changes in RET tracer uptake will be analyzed in relation to clinical disease progression and compared with pathology, serum markers, and other imaging findings to evaluate the value of RET-targeted PET/CT for early treatment response assessment.
Time frame: During follow-up after treatment (repeat imaging at least 1 week apart when needed)
Plan to share: No
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