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

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Prostate CA

Treatments: Drug: 68Ga-PSMA-CYC; Drug: CYC

Study type: Interventional

Funder types: Other

Identifiers

NCT07056790

FAHFJ-68Ga-PSMAcyc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Patients will undergo a 68Ga-PSMA-CYC PET/CT 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT

Active Comparator group

Description:

Prostate Patients received 68Ga-PSMA-CYC 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT imaging within one week. Tracer doses of 68Ga-PSMA-CYC、68Ga-PSMA-617 or 68Ga-PSMA-11 will be used to image lesions of prostate cancer by PET/CT

Treatment:

Drug: 68Ga-PSMA-CYC

68Ga-PSMA-CYC

Experimental group

Description:

Experimental: dynamic PET scans PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 150 minutes after injection

Treatment:

Drug: CYC