Prostate cancer
Conditions
Interventions
Sponsors
The Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Adult male patients with low-risk and intermediate-risk prostate cancer; 2. The patient is between 45-85 years old; 3. There are no other metastases outside the prostate area; 4.PSA<20ng/ml; 5.T1a-T2c; 6. Gleason score <=7 points; 7. ECOG score<=2; 8. Lesions can be seen in imaging examination (the maximum diameter is less than or equal to 2cm) 9. Study participants voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with severe arrhythmia, history of epilepsy and recent massive myocardial infarction; 2. Patients with risk factors for pulmonary thromboembolism and coagulation dysfunction; 3. The patient's health condition cannot tolerate anesthesia; 4. The patient has an implanted pacemaker or other pacemaker in the body; 5. Those who have metal stents in the urethra, metal stents or other metal implants in the ablation area; 6. Acute infection or acute phase of chronic infection in the prostate area; 7. Those who are mentally abnormal or have a history of mental illness and cannot cooperate voluntarily; 8. Those who have participated in clinical trials of any drugs and/or medical devices within 3 months before enrollment; 9. Patients with a history of recurrence of prostate cancer with a history of previous surgery and/or drug treatment; 10. Patients with distant metastases 11. Patients who, in the opinion of the investigator, are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of clinically significant prostate cancer in the ablation area at 6 months after surgery (<20%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative PSA specific PFS (progression free survival);RECIST solid tumor evaluation;Imaging prostate volume (local tumor residual status, lesion volume changes);;Evaluation of overall functionality and stability:; | — |
Countries
China
Contacts
Public ContactNiu Yuanjie
The Second Hospital of Tianjin Medical University
Outcome results
None listed