Theranostic Applications of Radionuclides in Prostate Cancer

NCT07559201 | Recruiting DMC

• 1 other identifier: 2025XJSLL-10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer (Diagnosis)

Keywords

prostate cancer; PET/CT; ACP3

Outcome Measures

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.

  3 year

Secondary Outcomes (2)

• Number of lesions

  3 year

• SUV

  3 year

Study Arms (1)

ACP3 PET/CT

EXPERIMENTAL

Each subject receives a single intravenous injection of radiolabeld ACP3 and undergoes PET/CT imaging within the specified time.

Diagnostic Test: standard-of-care imaging (PSMA/FDG PET/CT), ACP3 PET/CT

Interventions

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.

ACP3 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Guilin Medical University, China: lead

Study Sites (1)

The First Affliated Hospital of Guilin Medical University

Guilin, Guangxi, 541001, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xingyu Mu, PhD

CONTACT

86 13347631119; muxingyu1992@hotmail.com

Wei Fu

CONTACT

86 13977385850; fuwei19700513@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Nuclear Medicine

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)