untreated high risk hormone-sensitive prostate cancer (PSA > 20 / Gleason score > 7 / T stage> cT2c)
Conditions
Interventions
Observation Group:None
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Males aged 18 years or older (adults, elderly). 2.Patients with prostate cancer confirmed by prostate biopsy. 3.Patients with high-risk prostate cancer according to the European Association of Urology (EAU) risk stratification system for prostate cancer (PSA > 20 ng/mL / Gleason score > 7 / T stage > cT2c). 4.Patients who have not received any local or systemic treatment for the primary prostate cancer lesion or metastases prior to FAPI PET imaging. 5.Patients who have undergone imaging with other imaging agents such as PSMA PET within one week before or after FAPI PET imaging. 6.Patients who are willing to undergo prostate cancer-related treatment and follow-up and will undergo corresponding imaging re-examination after a period of treatment.
Exclusion criteria
Exclusion criteria: 1.Patients who have received any anti-tumor treatment (including surgical treatment, endocrine therapy, chemotherapy, radiotherapy, immunotherapy, etc.) prior to FAPI PET imaging. 2.The interval between FAPI PET imaging and imaging with other imaging agents such as PSMA PET exceeds one week. 3.Patients with a known second malignancy that may complicate the interpretation of the images.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in imaging findings and prostate-specific antigen (PSA) after the patient receives treatment.;The positive detection rate, sensitivity, and specificity of FAPI PET at the patient level, lesion region level (primary tumor, pelvic lymph nodes, distant lymph nodes, bone, and viscera), and individ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the correlation between the imaging results of FAPI/FDG/PSMA PET and the clinical pathological characteristics of patients (PSA level, biopsy Gleason score, TNM staging).;Comparison of the correlation between the SUVmax of lesions detected by FAPI PET and PSMA PET and the histological expression of FAP and PSMA;Comparison of the distribution and uptake values of positive lesions detected by FAPI PET and FDG/PSMA PET; | — |
Countries
China
Contacts
Public ContactDong Liang and Chen Ruohua
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed