About this trial
The gastrin-releasing peptide receptor (GRPR) is highly expressed in prostate cancer (77%-100%). Numerous studies have confirmed that GRPR PET imaging has emerged as a significant molecular imaging modality in prostate cancer, particularly serving as a complementary tool to PSMA PET for addressing cases with negative or insufficient PSMA expression. It demonstrates substantial value in initial staging (especially in intermediate- and high-risk patients), detecting sites of biochemical recurrence, assessing metastatic lesions (notably in mCRPC), and guiding treatment decisions. 68Ga-G21 and 68Ga-G23 are two novel molecular probes targeting GRPR. This study aims to evaluate their biodistribution and diagnostic performance in prostate cancer and compare them with 68Ga-PSMA-11 PET imaging.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
confirmed treated or untreated prostate cancer patients;
signed written consent.
Disqualifiers
known allergy against PSMA;
any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Trial design
Parallel
Treatments tested in this trial
68Ga-G21
DrugIntravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-G21. Tracer of 68Ga-G21 will be used to image lesions of prostate cancer by PET imaging.
68Ga-G23
DrugIntravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-G23. Tracer of 68Ga-G23 will be used to image lesions of prostate cancer by PET imaging.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with Imaging Emergent Adverse Events
The distribution of adverse events (AE) will be done via the analysis of frequencies for imaging emergent Adverse Event, through the monitoring of relevant clinical and laboratory safety parameters.
Dosimetry data
Calculate the absorbed dose of 68Ga-G21 and 68Ga-G23 in normal organs.
Secondary outcomes
Diagnostic value
Sensitivity and Specificity of 68Ga-G21 and 68Ga-G23 PET imaging for prostate cancer in comparison with 68Ga-PSMA-11 PET imaging.
Sponsors and contacts
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