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Recruiting Phase 1, Phase 2 NCT07363382

NCT07363382 The Value of GRPR PET Imaging for Diagnosis and Staging in Prostate Cancer

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Clinical Trial Summary
NCT ID NCT07363382
Status Recruiting
Phase Phase 1, Phase 2
Sponsor First Affiliated Hospital of Fujian Medical University
Condition Prostate Cancer (Adenocarcinoma)
Study Type INTERVENTIONAL
Enrollment 6 participants
Start Date 2025-12-20
Primary Completion 2026-12-31

Trial Parameters

Condition Prostate Cancer (Adenocarcinoma)
Sponsor First Affiliated Hospital of Fujian Medical University
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 6
Sex MALE
Min Age 18 Years
Max Age 90 Years
Start Date 2025-12-20
Completion 2026-12-31
Interventions
68Ga-G2168Ga-G23

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Brief 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 Criteria

Inclusion Criteria: * confirmed treated or untreated prostate cancer patients; * signed written consent. Exclusion Criteria: * known allergy against PSMA; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

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