Prostate Cancer
Conditions
Interventions
Gold Standard:prostate biopsy pathology
Index test:AI-guided PSMA PET-MRI-US fusion biopsy pathology,MRI-US fusion biopsy pathology,systematic biopsy pathology
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.History of at least one previous systematic prostate biopsy (± targeted biopsy), with final pathology not diagnosing clinically significant prostate cancer. 2.Clinical indication for repeat biopsy, including (any one of the following): - Serum total PSA persistently > 4 ng/mL, or PSA velocity > 0.75 ng/mL/year; - Free/total PSA ratio 0.15 ng/mL^2; - Suspicious digital rectal examination; - Previous imaging suggesting new or progressive suspicious lesions. 3.Able to tolerate mpMRI, PSMA PET/CT, and transperineal prostate biopsy. 4.Understands the study content and signs written informed consent; 5. age 45-85 years old, male.
Exclusion criteria
Exclusion criteria: 1.Previous diagnosis of prostate cancer with definitive treatment (such as prostatectomy, radiotherapy, endocrine therapy, etc.); 2.Absolute contraindications to mpMRI (such as non-compatible cardiac pacemaker) or severe allergy to PSMA tracer components; 3.Severe renal insufficiency; 4.Unable to cooperate with the required positioning or anesthesia for the study; 5.Active infection or uncorrected coagulation disorders, contraindicating biopsy procedures; 6.Investigator judgment of other serious diseases with life expectancy less than 2 years, or participation in the study may pose unacceptable risks; 7.Participation in other interventional clinical trials within the past 3 months that may interfere with the determination of study endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of prostate cancer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incremental Cost-Effectiveness Ratio (ICER);Overdiagnosis rate of clinically insignificant prostate cancer;Avoiding unnecessary biopsy rates; | — |
Countries
China
Contacts
Public ContactHuang Yuhua
The First Affiliated Hospital of Soochow University
Outcome results
None listed