68Ga-XMFH01 PET/FL imaging to guide prostate cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, interventional study evaluates the feasibility, safety, and diagnostic performance of the ACP3-targeted probe 68Ga-XMFH01 for both PET/CT imaging before surgery and intraoperative fluorescence guidance in prostate cancer patients. Participants will undergo preoperative PET/CT to assess disease extent and quantify tumor uptake (SUVmax). During surgery, fluorescence imaging will help identify tumor tissue and assess margins, with concordance to histopathology assessed as the reference standard. The study will also compare preoperative PET/CT accuracy against surgical and histopathologic findings to determine overall diagnostic value. Safety and feasibility of this dual-modality approach will be evaluated in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 with regional pelvic lymph node metastases (N1) are eligible for inclusion;
* 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.

Exclusion Criteria:

* 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.

Where it's running

• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting

Study contacts

• Study coordinator: Liang Zhao, MD
• Email: wzhaoliang01@163.com
• Phone: 18818350620

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.