NCT07056790

Research on the Application of 68Ga-PSMA-CYC PET Imaging in the Diagnosis, Staging, and Restaging of Prostate Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: First Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

68Ga-PSMA-CYC is a novel radiotracer targeting PSMA. In this study, we investigated the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.

Detailed description

Prostate cancer (PCa) is one of the most common malignant tumors among men worldwide. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein that is highly expressed in PCa and its metastatic lesions, making it an ideal target for the precise diagnosis and treatment of PCa. Various low-molecular-weight radiopharmaceuticals targeting PSMA have been developed, such as PSMA-11 and PSMA-617, which can be labeled with 68Ga or 177Lu. 68Ga-PSMA-CYC is a novel radiotracer that has demonstrated favorable in vivo and in vitro stability in preliminary studies, with specific accumulation in PCa, high binding affinity, and good safety profile, making it a promising candidate for further investigation. This prospective study aims to investigate the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.

Conditions

• Prostate CA

Interventions

Type	Name	Description
DRUG	68Ga-PSMA-CYC	Each prostate cancer patient underwent a 68Ga-PSMA-CYC (3-4 mCi) PET/CT scan, as well as a 68Ga-PSMA-617 (3-4 mCi) or 68Ga-PSMA-11 (3-4 mCi) PET/CT scan, with the time interval between the two scans not exceeding one week.
DRUG	CYC	The dose will be 3-4mCi given intravenously.

Timeline

• Start date: 2025-05-15
• Primary completion: 2027-02-01
• Completion: 2027-05-01
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: China