68Ga-XACP3 PET/CT in Prostate Cancer

November 17, 2025 updated by: The First Affiliated Hospital of Xiamen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-XACP3
Each subject receives a single intravenous injection of 68Ga-XACP3 and undergoes PET/CT imaging within the specified time.
Diagnostic test: Diagnostic Test: standard-of-care imaging (68Ga-PSMA PET/CT), 68Ga-XACP3 PET/CT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 years
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.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMYY-2025KY231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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