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Prostatic NeoplasmsPhase 2NCT07830212

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

A Phase 2 study testing [68Ga]Ga-OncoACP3 in people with Prostatic Neoplasms and Prostate Cancer, run by Yong He at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Prostatic Neoplasms, Prostate Cancer
What is being tested?
[68Ga]Ga-OncoACP3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
Oct 2026to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
  • Inability to complete PET/CT examination, including inability to lie flat, claustrophobia, or radiophobia;
  • Poor compliance or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yong He, MD, PhD contact

027-67812837

heyong@whu.edu.cn

China1 site

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Yong He, MD, PhD, 027-67812837, heyong@whu.edu.cn

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

Background Prostate cancer is the second most common cancer in men worldwide. Accurate diagnosis, staging, and risk stratification are critical for optimal management. PSMA PET imaging has improved prostate cancer detection but has limitations, including heterogeneous PSMA expression leading to false negatives, and physiological uptake in salivary glands, liver, spleen, and intestine that can obscure lesions or cause false-positive findings. ACP3 (prostate acid phosphatase, PAP) is highly and homogeneously expressed in more than 95% of prostate cancer lesions but has low expression in healthy tissues. OncoACP3 is a small-molecule ligand with picomolar affinity for ACP3. Preclinical and early clinical studies suggest that [68Ga]Ga-OncoACP3 PET has favorable biodistribution, low background uptake, and high tumor-to-background ratios, potentially outperforming PSMA PET in certain settings.

Study Objectives Primary objective: To prospectively evaluate the lesion detection rate and diagnostic performance (including sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) of [68Ga]Ga-OncoACP3 PET imaging in men with clinically suspected or confirmed high-risk prostate cancer, or suspected recurrence after treatment.

Secondary objectives: (1) comparison with [68Ga]Ga-PSMA PET imaging in participants who have already undergone clinically routine PSMA PET; (2) correlation of semi-quantitative parameters derived from [68Ga]Ga-OncoACP3 PET imaging with pathological markers (ACP3 expression assessed by immunohistochemistry in tumor tissue); (3) evaluation of the impact of [68Ga]Ga-OncoACP3 PET imaging on clinical treatment decisions.

Study Design This is a prospective, single-arm, single-center, open-label clinical study enrolling 50 male participants aged 18 to 90 years with clinically suspected or confirmed high-risk prostate cancer, or suspected recurrence after treatment. After enrollment and informed consent, participants will undergo [68Ga]Ga-OncoACP3 PET/CT imaging within 1 week. A single intravenous dose of 3-5 mCi [68Ga]Ga-OncoACP3 will be administered, followed by PET/CT imaging at 1 hour post-injection. For participants who have already undergone clinically routine PSMA PET imaging, a comparison between the two imaging modalities will be performed. Image analysis will include visual qualitative assessment and semi-quantitative analysis (e.g., standardized uptake value). The gold standard for diagnosis will be histopathological examination and/or clinical follow-up of at least 6 months. The study will also assess the correlation between semi-quantitative PET parameters and ACP3 expression in tumor tissue, and evaluate the impact of imaging findings on clinical management.

Being tested
[68Ga]Ga-OncoACP3
Keywords
Prostate acid phosphatase, [68Ga]Ga-OncoACP3 PET/CT, Diagnostic performance, Prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [68Ga]Ga-OncoACP3Drug

    Also called OncoACP3

    [68Ga]Ga-OncoACP3 is a small-molecule PET imaging agent targeting ACP3 (prostate acid phosphatase). It is radiolabeled with Gallium-68 and administered as a single intravenous dose of 3-5 mCi. PET/CT imaging is performed at about 1 hour post-injection.

Study groups in NCT07830212
Study groupRoleWhat they receive
[68Ga]Ga-OncoACP3 PET ImagingExperimentalParticipants receive a single intravenous injection of 3-5 mCi [68Ga]Ga-OncoACP3, followed by PET/CT imaging at about 1 hour post-injection.
Receives: Drug: [68Ga]Ga-OncoACP3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lesion Detection Rate of [68Ga]Ga-OncoACP3 PET Imaging

    Proportion of participants with at least one prostate cancer lesion detected by [68Ga]Ga-OncoACP3 PET/CT imaging, using histopathology and/or clinical follow-up of at least 6 months as the reference standard.

    Measured: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging

  2. Sensitivity of [68Ga]Ga-OncoACP3 PET Imaging

    Sensitivity of [68Ga]Ga-OncoACP3 PET/CT imaging for detecting tumor lesions, using histopathology and/or clinical follow-up of at least 6 months as the reference standard.

    Measured: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging

  3. Specificity of [68Ga]Ga-OncoACP3 PET Imaging

    Specificity of [68Ga]Ga-OncoACP3 PET/CT imaging for detecting tumor lesions, using histopathology and/or clinical follow-up of at least 6 months as the reference standard.

    Measured: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging

  4. Accuracy of [68Ga]Ga-OncoACP3 PET Imaging

    Accuracy of [68Ga]Ga-OncoACP3 PET/CT imaging for detecting tumor lesions, using histopathology and/or clinical follow-up of at least 6 months as the reference standard.

    Measured: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging

Secondary outcomes (3)

  1. Comparison with [68Ga]Ga-PSMA PET Imaging

    Comparison of lesion detection rate and diagnostic performance between [68Ga]Ga-OncoACP3 PET/CT and [68Ga]Ga-PSMA PET/CT in participants who have undergone clinically routine PSMA PET imaging.

    Measured: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging

  2. Correlation Between Semi-Quantitative PET Parameters and ACP3 Expression

    Correlation between semi-quantitative parameters (e.g., standardized uptake value) derived from [68Ga]Ga-OncoACP3 PET imaging and ACP3 expression assessed by immunohistochemistry in tumor tissue.

    Measured: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging

  3. Impact on Clinical Treatment Decisions

    Proportion of participants whose clinical treatment decisions were changed based on [68Ga]Ga-OncoACP3 PET imaging findings.

    Measured: Within 1 month after [68Ga]Ga-OncoACP3 PET imaging

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive a single intravenous injection of \[68Ga\]Ga-OncoACP3 followed by PET/CT imaging at about 1 hour post-injection. For participants who have already undergone clinically routine PSMA PET imaging, a head-to-head comparison between the two imaging modalities will be performed. No randomization or blinding is applied.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07830212
Sponsor's protocol ID
LYL2026287
Status last verified
Sep 2026
First submitted
15 Sep 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liang SH. ACP3-targeted PET imaging agents based on small-molecule ligands for prostate cancer diagnostics and theranostics. Am J Nucl Med Mol Imaging. 2026 Jun 25;16(3):157-161. doi: 10.62347/LKNT6446. eCollection 2026.

    PubMed 42495193

  • Seifert KE, Reimann J, Rust M, Bogemann M, Schrader AJ, Schafers M, Bernemann C, Backhaus P. The prostatic acid phosphatase in prostate cancer: A novel theranostic target. Semin Nucl Med. 2026 Jul;56(4):748-758. doi: 10.1053/j.semnuclmed.2026.03.004. Epub 2026 Apr 1.

    PubMed 41925410

  • Brosch-Lenz J, Buther F, Oehler S, Ciamarone A, Georgiev T, Schindler P, Landau F, Breyholz HJ, Ventura D, Rust M, Schlack K, Bogemann M, Puca E, Mock J, Cazzamalli S, Neri D, Rahbar K, Schrader AJ, Schafers M, Seifert KE, Backhaus P. Dynamics, Pharmacokinetics, and Dosimetry of First-in-Human [68Ga]Ga-OncoACP3-DOTA PET in Patients with Prostate Cancer. J Nucl Med. 2026 Jul 1;67(7):1079-1085. doi: 10.2967/jnumed.125.271933.

    PubMed 42061944

  • Backhaus P, Cazzamalli S, Oehler S, Buther F, Brosch-Lenz J, Landau F, Breyholz HJ, Claesener M, Migliorini F, Ciamarone A, Georgiev T, Mock J, Ventura D, Barca C, Schiefelbein L, Hermann S, Schafers K, Gierse F, Bernemann C, Schlack K, Bogemann M, Puca E, Schindler P, Neri D, Rahbar K, Schrader AJ, Seifert KE, Schafers M. Translational and First-in-Human Positron Emission Tomography Targeting Prostatic Acid Phosphatase in Prostate Cancer Using the Ligand [68Ga]Ga-OncoACP3-DOTA. Eur Urol. 2026 Apr;89(4):305-310. doi: 10.1016/j.eururo.2025.11.025. Epub 2025 Dec 17.

    PubMed 41412909

  • Georgiev T, Migliorini F, Ciamarone A, Mueller M, Biancofiore I, Faviana P, Bartoli F, Park Kim YS, Principi L, Gilardoni E, Bassi G, Favalli N, Puca E, Neri D, Oehler S, Cazzamalli S. Discovery of high-affinity ligands for prostatic acid phosphatase via DNA-encoded library screening enables targeted cancer therapy. Nat Biomed Eng. 2026 Jan;10(1):178-191. doi: 10.1038/s41551-025-01432-6. Epub 2025 Jun 26.

    PubMed 40571760

  • Heller JE. Prostatic acid phosphatase: its current clinical status. J Urol. 1987 Jun;137(6):1091-103. doi: 10.1016/s0022-5347(17)44414-4. No abstract available.

    PubMed 3295298

  • Sheikhbahaei S, Werner RA, Solnes LB, Pienta KJ, Pomper MG, Gorin MA, Rowe SP. Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer: An Update on Important Pitfalls. Semin Nucl Med. 2019 Jul;49(4):255-270. doi: 10.1053/j.semnuclmed.2019.02.006. Epub 2019 Mar 4.

    PubMed 31227049

  • Bukavina L, Luckenbaugh AN, Hofman MS, Hope T, Kamran SC, Murphy DG, Yamoah K, Ost P. Incorporating Prostate-specific Membrane Antigen Positron Emission Tomography in Management Decisions for Men with Newly Diagnosed or Biochemically Recurrent Prostate Cancer. Eur Urol. 2023 Jun;83(6):521-533. doi: 10.1016/j.eururo.2022.10.024. Epub 2022 Nov 18.

    PubMed 36404204

  • Hofman MS, Lawrentschuk N, Francis RJ, Tang C, Vela I, Thomas P, Rutherford N, Martin JM, Frydenberg M, Shakher R, Wong LM, Taubman K, Ting Lee S, Hsiao E, Roach P, Nottage M, Kirkwood I, Hayne D, Link E, Marusic P, Matera A, Herschtal A, Iravani A, Hicks RJ, Williams S, Murphy DG; proPSMA Study Group Collaborators. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 2020 Apr 11;395(10231):1208-1216. doi: 10.1016/S0140-6736(20)30314-7. Epub 2020 Mar 22.

    PubMed 32209449

  • Han S, Woo S, Kim YJ, Suh CH. Impact of 68Ga-PSMA PET on the Management of Patients with Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2018 Aug;74(2):179-190. doi: 10.1016/j.eururo.2018.03.030. Epub 2018 Apr 18.

    PubMed 29678358

  • Wang Y, Galante JR, Haroon A, Wan S, Afaq A, Payne H, Bomanji J, Adeleke S, Kasivisvanathan V. The future of PSMA PET and WB MRI as next-generation imaging tools in prostate cancer. Nat Rev Urol. 2022 Aug;19(8):475-493. doi: 10.1038/s41585-022-00618-w. Epub 2022 Jul 4.

    PubMed 35789204

  • De Man K, Van Laeken N, Schelfhout V, Fendler WP, Lambert B, Kersemans K, Piron S, Lumen N, Decaestecker K, Fonteyne V, Delrue L, De Vos F, Ost P. 18F-PSMA-11 Versus 68Ga-PSMA-11 Positron Emission Tomography/Computed Tomography for Staging and Biochemical Recurrence of Prostate Cancer: A Prospective Double-blind Randomised Cross-over Trial. Eur Urol. 2022 Nov;82(5):501-509. doi: 10.1016/j.eururo.2022.05.010. Epub 2022 Jun 8.

    PubMed 35690515

  • Prive BM, Israel B, Janssen MJR, van der Leest MMG, de Rooij M, van Ipenburg JA, Jonker M, Peters SMB, de Groot M, Zamecnik P, Hoepping A, Bomers JG, Gotthardt M, Sedelaar JPM, Barentsz JO, van Oort IM, Nagarajah J. Multiparametric MRI and 18F-PSMA-1007 PET/CT for the Detection of Clinically Significant Prostate Cancer. Radiology. 2024 May;311(2):e231879. doi: 10.1148/radiol.231879.

    PubMed 38771185

  • Hicks RM, Simko JP, Westphalen AC, Nguyen HG, Greene KL, Zhang L, Carroll PR, Hope TA. Diagnostic Accuracy of 68Ga-PSMA-11 PET/MRI Compared with Multiparametric MRI in the Detection of Prostate Cancer. Radiology. 2018 Dec;289(3):730-737. doi: 10.1148/radiol.2018180788. Epub 2018 Sep 18.

    PubMed 30226456

  • James ML, Gambhir SS. A molecular imaging primer: modalities, imaging agents, and applications. Physiol Rev. 2012 Apr;92(2):897-965. doi: 10.1152/physrev.00049.2010.

    PubMed 22535898

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [68Ga]Ga-OncoACP3 in people with Prostatic Neoplasms and Prostate Cancer, run by Yong He at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yong He, MD, PhD (027-67812837, heyong@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lesion Detection Rate of [68Ga]Ga-OncoACP3 PET Imaging (time frame: Up to 6 months after [68Ga]Ga-OncoACP3 PET imaging). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07830212, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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