Clinical Trial · NCT07830212

Diagnostic Performance of ACP3-Targeted PET Imaging in Patients With Primary and Recurrent Prostate Cancer: An Open-Label, Single-Arm, Single-Center Study

Overview

This study aims to evaluate the diagnostic performance of \[68Ga\]Ga-OncoACP3 PET imaging, which targets prostate acid phosphatase (ACP3), in men with clinically suspected or confirmed high-risk prostate cancer, or suspected recurrence after treatment. The study will assess the ability of this imaging to detect lesions and its diagnostic performance, including sensitivity, specificity, and accuracy. Histopathology and/or clinical follow-up of at least 6 months will be used as the reference standard. Participants will receive a single intravenous injection of \[68Ga\]Ga-OncoACP3 and undergo a PET/CT scan about 1 hour later. For participants who have already undergone clinically routine PSMA PET imaging, a comparison between the two imaging modalities will be performed. The study will enroll 50 men aged 18 to 90 years. Additionally, the study will explore the correlation between semi-quantitative parameters derived from \[68Ga\]Ga-OncoACP3 PET imaging and pathological markers (ACP3 expression assessed by immunohistochemistry in tumor tissue), and will evaluate the impact of \[68Ga\]Ga-OncoACP3 PET imaging on clinical treatment decisions.

Sponsor

Zhongnan Hospital

Phase

Phase 2

Contacts

Yong He, MD, PhD (CONTACT)

heyong@whu.edu.cn

027-67812837

ClinicalTrials.gov

NCT07830212

Drug / Compound

OncoACP3

Isotope(s):

Target(s):

ACP3

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Clinically suspected high-risk, histologically confirmed, or suspected recurrent prostate cancer after treatment;

Exclusion

Inability to complete PET/CT examination, including inability to lie flat, claustrophobia, or radiophobia;
Prior use of a radiopharmaceutical within less than 10 physical half-lives before study drug administration;
Known or suspected allergy to \[68Ga\]Ga-OncoACP3 injection or any of its excipients;
Any severe unstable disease (e.g., severe cardiac, pulmonary, hepatic, or renal insufficiency) that, in the investigator's judgment, makes the participant unsuitable for the study;
Poor compliance or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study;