Prostate cancer
Conditions
Interventions
Single group:Pulsed electric field ablation
Sponsors
RenJi Hospital Affiliated to Shanghai Jiaotong University School of Medical
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Male above the age of 40 (including 40 years old); 2) Preoperative pathological analysis or imaging diagnosis of untreated prostate cancer, satisfying the tumor T stage of T1a-T2c, Gleason score =5 years; 6) The subject or his/her legal guardian can understand the study purpose, demonstrate adequate compliance with the study protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who have received any previous treatment for prostate cancer, including but not limited to surgery, hormone therapy, chemotherapy, radiotherapy, targeted therapy and immunotherapy; 2) Complicated with other malignant tumors, or in the acute infection phase or other severe infections, such as severe urinary system infection; 3) Electronic devices and metal parts such as pacemakers or defibrillators are implanted in or near the ablation area; 4) Patients with a history of severe arrhythmia, epilepsy or recent large-scale myocardial infarction; 5) Complicated with serious heart, liver, kidney, brain disease or coagulopathy; 6) Patients who have participated in clinical studies of other drugs, biologics or devices within 3 months; 7) Situations in which other investigators deem it inappropriate to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of clinically significant prostate cancer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of solid tumor ablation (mRECIST);Biochemical recurrence rate of serum PSA;International Prostate Symptom Score;Normal urinary control rate;International erectile function score 5 items;Evaluation on the convenience of device use;Device stability evaluation; | — |
Countries
China
Contacts
Public ContactWei Xue
RenJi Hospital Affiliated to Shanghai Jiaotong University School of Medical
Outcome results
None listed