Health TrialsbyHealthPanel

Theranostic Applications of Radionuclides in Prostate Cancer

ConditionProstate Cancer (Diagnosis)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorGuilin Medical University, China

About this trial

The objective of the study is to construct a noninvasive approach ACP3 targeted PET/CT to detect tumor lesions in patients with prostate cancer and to compare with PSMA/FDG PET/CT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (aged 18 years or older);

Patients with newly diagnosed, highly suspected recurrence or previously treated metastases of prostate cancer (supporting evidence may include MRI, CT, tumor markers, and pathology report);

Patients who had scheduled both standard-of-care imaging (PSMA/FDG PET/CT) and ACP3 PET/CT scans;

Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Disqualifiers

The inability or unwillingness of the research participant or legal representative to provide written informed consent.

Trial design

Design model

Single group

Treatments tested in this trial

  • standard-of-care imaging (PSMA/FDG PET/CT), ACP3 PET/CT

    Diagnostic test

    Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceutical (PSMA/FDG) and ACP3, and undergoes PET/CT imaging within the specified time.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: ACP3 PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic efficacy

The sensitivity, specificity, and accuracy of standard-of-care imaging (PSMA/FDG PET/CT) and ACP3 PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Time frame
3 year

Secondary outcomes

1

Number of lesions

The numbers of positive primary and metastatic lesions of standard-of-care imaging (PSMA/FDG PET/CT) and ACP3 PET/CT were recorded by visual interpretation.

Time frame
3 year
2

SUV

Standardized uptake value (SUV) of standard-of-care imaging (PSMA/FDG PET/CT) and ACP3 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.

Time frame
3 year

Other outcomes

Sponsors and contacts

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

Guilin Medical University, China

Lead sponsor

Source ClinicalTrials.gov
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