The Value of GRPR PET Imaging for Diagnosis and Staging in Prostate Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

68Ga-G21: Intravenous 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: Intravenous 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.

Study summary

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

Primary outcome measure(s)

• Number of participants with Imaging Emergent Adverse Events — From enrollment till 7 days safety follow-up
  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 — through study completion, an average of 3 months
  Calculate the absorbed dose of 68Ga-G21 and 68Ga-G23 in normal organs.

Trial sites (1)

More First Affiliated Hospital of Fujian Medical University trials in China

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