Research on the Application of 68Ga-PSMA-CYC PET Imaging in the Diagnosis, Staging, and Restaging of Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-PSMA-CYC, CYC.
- Who it may be relevant to
- Registry conditions: Prostate CA. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Diagnostic value [Time frame: through study completion, an average of 1year]
- Adverse events [Time frame: Within 7 days following PET/CT]
Secondary outcome measures (1)
- Dosimetry data [Time frame: through study completion, an average of 3 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- The First Affiliated Hospital of Fujian Medical University — Fuzhou
Identifiers
NCT: NCT07056790 · FAHFJ-68Ga-PSMAcyc