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Recruiting NCT07559201

Theranostic Applications of Radionuclides in Prostate Cancer

No phase Interventional Prostate Cancer (Diagnosis)

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: standard-of-care imaging (PSMA/FDG PET/CT), ACP3 PET/CT.
Who it may be relevant to
Registry conditions: Prostate Cancer (Diagnosis). Basic parameters: from 18 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 →
Official title

ACP3 Targeted -PET/ CT in Prostate Cancer

Overview

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.

Detailed description

ACP3 targeting PET radiotracer is promising as an excellent imaging agent applicable to prostate cancer. In this research, subjects with prostate cancer or highly suspected recurrence detection underwent contemporaneous ACP3 PET/CT and standard-of-care imaging (PSMA/FDG PET/CT) either for an initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care imaging and 68Ga-PSMA PET/CT were recorded by visual interpretation. The diagnostic accuracy of ACP3 PET/CT was calculated and compared to standard-of-care imaging.

Interventions

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

Primary outcome measures

  • Diagnostic efficacy [Time frame: 3 year]
Secondary outcome measures (2)
  • Number of lesions [Time frame: 3 year]
  • SUV [Time frame: 3 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • The First Affliated Hospital of Guilin Medical University — Guilin

Identifiers

NCT: NCT07559201 · 2025XJSLL-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗