68Ga-XACP3 PET/CT in Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer PET/CT ACP3

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-XACP3

Each subject receives a single intravenous injection of 68Ga-XACP3 and undergoes PET/CT imaging within the specified time.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.