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NCT Number: NCT07242014

68Ga-XACP3 PET/CT in Prostate Cancer

The objective of the study is to construct a noninvasive approach 68Ga-XACP3 PET/CT to detect tumor lesions in patients with prostate cancer and to compare with 68Ga-PSMA PET/CT.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

Location status: Recruiting

Location contact

About this study

As a new ACP3 targeting PET radiotracer, 68Ga-XACP3 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 68Ga-XACP3 and standard-of-care imaging (68Ga-PSMA 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 68Ga-XACP3 was calculated and compared to standard-of-care imaging.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (68Ga-PSMA PET/CT) and 68Ga-XACP3 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.

Treatment and study plan

Diagnostic Test: standard-of-care imaging (68Ga-PSMA PET/CT), 68Ga-XACP3 PET/CT

Diagnostic Test

Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceutical (68Ga-PSMA) and 68Ga-XACP3, and undergoes PET/CT imaging within the specified time.

Primary outcomes

  1. Diagnostic efficacy

    Time frame: 1 years

    Description: The sensitivity, specificity, and accuracy of standard-of-care imaging (68Ga-PSMA PET/CT) and 68Ga-XACP3 PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Secondary outcomes

  1. Number of lesions

    Time frame: 1 years

    The numbers of positive primary and metastatic lesions of standard-of-care imaging (68Ga-PSMA PET/CT) and 68Ga-XACP3 PET/CT were recorded by visual interpretation.

  2. SUV

    Time frame: 1 years

    Standardized uptake value (SUV) of standard-of-care imaging (68Ga-PSMA PET/CT) and 68Ga-XACP3 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.

Study contacts

Contact information is provided by the study sponsor or research team.

Haojun Chen, MD, PhD

CONTACT

[email protected]

86 18659285282

Liang Zhao

CONTACT

[email protected]

86 18818350620

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

PET Targeting Acid Phosphatase 3 (ACP3) in Prostate Cancer and Compared With 68Ga-PSMA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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