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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18-90
SponsorFirst Affiliated Hospital of Fujian Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 68Ga-G21

    Drug

    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

    Drug

    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.

Treatment groups

6 Participants
are divided into 2 treatment groups
Group A: 68Ga-G21 PET imagingExperimental treatment 1 intervention
Group B: 68Ga-G23 PET imagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment till 7 days safety follow-up
2

Dosimetry data

Calculate the absorbed dose of 68Ga-G21 and 68Ga-G23 in normal organs.

Time frame
through study completion, an average of 3 months

Secondary outcomes

1

Diagnostic value

Sensitivity and Specificity of 68Ga-G21 and 68Ga-G23 PET imaging for prostate cancer in comparison with 68Ga-PSMA-11 PET imaging.

Time frame
through study completion, an average of 3 months

Other outcomes

Sponsors and contacts

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