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

ConditionProstate CA
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorFirst Affiliated Hospital of Fujian Medical University

About this trial

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.

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

Single group

Treatments tested in this trial

  • 68Ga-PSMA-CYC

    Drug

    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.

  • CYC

    Drug

    The dose will be 3-4mCi given intravenously.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Patients will undergo a 68Ga-PSMA-CYC PET/CT 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CTActive comparator 1 intervention
Group B: 68Ga-PSMA-CYCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic value

Sensitivity and Specificity of 68Ga-PSMA-CYC for prostate cancer in comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 PET/CT.

Time frame
through study completion, an average of 1year
2

Adverse events

The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

Time frame
Within 7 days following PET/CT

Secondary outcomes

1

Dosimetry data

Calculate the absorbed dose of 68Ga-PSMAcyc in normal organs.

Time frame
through study completion, an average of 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Fujian Medical University

Lead sponsor

Source ClinicalTrials.gov
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