NCT07885423

Brief Summary

This study aims to evaluate the feasibility, safety, and diagnostic performance of 68Ga-XMFH01, a novel ACP3-targeted dual-modality PET and fluorescence imaging probe, for preoperative PET/CT imaging and intraoperative fluorescence-guided surgery in patients with prostate cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

October 21, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

October 21, 2026

Status Verified

September 1, 2026

Enrollment Period

11 months

First QC Date

October 14, 2026

Last Update Submit

October 14, 2026

Conditions

Prostate Cancer (Diagnosis)ACP3PET / CT

Keywords

Prostate CancerACP3PET/CT

Outcome Measures

Primary Outcomes (1)

  • Diagnostic efficacy

    Description: The sensitivity, specificity, and accuracy of 68Ga-XMFH01 PET/CT were calculated to evaluate the diagnostic accuracy.

    1 month

Secondary Outcomes (2)

  • Concordance Between Intraoperative Fluorescence Imaging and Histopathology for Prostate Surgical Margin Assessment

    1 month

  • Concordance Between Intraoperative Fluorescence Imaging and Histopathology for Pelvic Lymph Node Assessment

    1 month

Study Arms (1)

68Ga-XMFH01

EXPERIMENTAL

Participants will undergo preoperative 68Ga-XMFH01 PET/CT imaging for tumor detection and localization, followed by intraoperative fluorescence-guided surgical navigation using the same dual-modality probe.

Diagnostic Test: 68Ga-XMFH01 PET/CT

Interventions

68Ga-XMFH01 PET/CTDIAGNOSTIC_TEST

Each participant will receive a single intravenous injection of 68Ga-XMFH01, a novel HER2-targeted radiotracer, followed by PET/CT imaging to noninvasively assess HER2 expression in tumor lesions.

68Ga-XMFH01

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with prostate cancer who are scheduled to undergo surgical treatment;
  • Adult patients (aged 18 years or older);
  • No evidence of distant metastases (M0), including nonregional lymph node metastases, bone metastases, or visceral metastases, as determined by conventional imaging (bone scintigraphy, CT, or MRI) or PET/CT;
  • Patients who have been fully informed of their disease status, treatment options, and study procedures, and who voluntarily provide written informed consent;
  • Patients who are willing and able to comply with the study protocol, including scheduled visits, treatment procedures, and required laboratory and imaging examinations.

You may not qualify if:

  • Patients who are unwilling or unable to provide written informed consent or cooperate with study procedures;
  • Patients who are unable to tolerate PET/CT examinations;
  • Patients who have previously received any of the following treatments for prostate cancer: (a) Systemic therapy: More than 2 months of androgen deprivation therapy (ADT) or conventional hormonal therapy, or any prior treatment with novel hormonal agents, chemotherapy, immunotherapy, or targeted therapy. (b) Local therapy: Prior pelvic radiotherapy or surgery for prostate cancer;
  • Patients who are medically unfit for or unable to tolerate the planned surgical procedure for prostate cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsDisease

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Liang Zhao, MD

CONTACT

18818350620wzhaoliang01@163.com

Haojun Chen, MD, PhD

CONTACT

86 18659285282leochen0821@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2026

First Posted

October 21, 2026

Study Start

October 21, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

October 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)