68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer

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.

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.