Prostate cancer
Conditions
Interventions
Group A:IRE Guided by Traditional Cognitive Fusion
Group B:IRE Guided by Electromagnetic Navigation Combined with Real-time Image Planning
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=50 years; life expectancy >10 years; 2. Serum PSA =3), with histopathological confirmation of prostate cancer via mpMRI fusion-targeted biopsy or combined systematic and targeted biopsy; 4. Gleason score <=4+3 (ISUP grade group <=3); 5. Clinical TNM stage <=cT2c (based on digital rectal examination and mpMRI), N0 (based on mpMRI), and M0 (based on bone scintigraphy, with PSMA PET/CT when indicated); 6. Patient comprehension of the study protocol and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of radical treatment for prostate cancer (surgery, radiotherapy, other ablations, etc.); 2. History of local prostate treatment (such as transurethral resection of the prostate, excluding diagnostic puncture); 3. Presence of contraindications to mpMRI examination or contraindications to transrectal ultrasound/transperineal procedures; 4. Evidence of distant metastasis (bone scan or PSMA-PET/CT, etc.); 5. Absolute surgical contraindications such as uncorrectable coagulation dysfunction, inability to tolerate general anesthesia, or complicated with severe visceral organ dysfunction diseases; 6. Presence of a cardiac pacemaker or defibrillator implantation that cannot be safely paused/removed (potential interference from IRE); 7. Presence of active rectal inflammation, fistula, or severe anal stenosis; 8. Cognitive impairment or inability to comply with study follow-up requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive biopsy rate at 12 months postoperatively;Local recurrence-free survival period;Regional recurrence-free survival period;Biochemical recurrence-free survival period;Rate of secondary intervention(s); | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation time;Ablation accuracy;Intraoperative complications;Postoperative Adverse Events;Function retention status; | — |
Countries
China
Contacts
Public ContactNiu Shaoxi, Wang Baojun
Chinese PLA General Hospital
Outcome results
None listed