NCT07830212Not yet recruitingPhase 2
Diagnostic Performance of ACP3-Targeted PET Imaging in Patients With Primary and Recurrent Prostate Cancer: An Open-Label, Single-Arm, Single-Center Study
A Study to Evaluate the Diagnostic Performance of ACP3-Targeted PET Imaging in Patients With Primary and Recurrent Prostate Cancer: An Open-Label, Single-Arm, Single-Center Study
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 15 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Yong He
- Diseases
- Prostate cancer
- NCT number
- NCT07830212
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 1 Oct 2026 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of a radiopharmaceutical within less than 10 physical half-lives before study drug administration;
- Currently participating in or planning to participate in any drug or device clinical trial during the study period.
Other illness
- 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;
Other
- Inability to complete PET/CT examination, including inability to lie flat, claustrophobia, or radiophobia;
Who the study is looking for
- Voluntary participation and signed written informed consent before any study-specific procedures;
- Male, aged 18 to 90 years;
- Clinically suspected high-risk, histologically confirmed, or suspected recurrent prostate cancer after treatment;
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study-related procedures;
- Expected survival time greater than 6 months;
- Participants' partners agree to use reliable contraceptive measures (such as abstinence, sterilization surgery, oral contraceptives, injectable medroxyprogesterone acetate, or subdermal implants) during the study and for at least 6 months after the last dose of study drug.
Age in the registry: 18 years to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.