Prostate cancer
Conditions
Interventions
Subjects:ExAblateTM prostate ablation
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male aged 50 years old and more; 2. Life expectancy> 10 years; 3. Prostate volume <60 cc; 4. PSA = 10 ng / ml; 5. Transrectal or perineum expansion of the imaging guide biopsy histological results proved to be prostate cancer; 6. Positioning biopsy based on extended imaging has the following results:A. T1-T2b (detection of prostate unilateral positive lesions)B. At least one lesion Gleason score of 7 (= 3 + 4 or 4 + 3; no grade 5 structure type)C. If other lesions are found in the same leaf, the Gleason score requires <7 (= 3 + 4 or 4 + 3; no grade 5 structure type)D. N0, M0; 7. MRI must be visible indicative of the lesion; 8. MRI showed that any cancerous lesion had a short diameter of <15 mm; 9. The length of the tumor in contact with the prostate cyst <5mm; 10. Uncoated extension; 11. does not violate the seminal vesicle; 12. Patients with body weight <113 Kg; 13. The patient is suitable for epidural anesthesia or general anesthesia (as determined by an anesthesiologist); 14. The patient has the will and the ability to sign informed consent and participate in all the study visits specified in the trial program.
Exclusion criteria
Exclusion criteria: 1. Detection of prostate cancer on the contralateral side of the existence of biopsy confirmed by MRI or suspected lesions; 2. ASA status score> 2 points; 3. There are any contraindications to MRI examinations, such as: 3.1. Size is too large to limit the location of the MRI scan hole on the patient; 3.2. Suffering from claustrophobia; 3.3. Implanted ferromagnetic material or foreign matter; 3.4. There is a contraindication to the use of MRI contrast agents (eg gadolinium / mangenvian); 4. severe coagulation dysfunction (INR> 1.5); 5. Patients with unstable cardiovascular status, including: 5.1. Drug treatment of unstable angina; 5.2. Myocardial infarction recorded within 90 days prior to enrollment; 5.3. NYHA class IV congestive heart failure; 5.4. Irritation of arrhythmia with antiarrhythmic drugs; 5.5. Severe high blood pressure (diastolic blood pressure> 100 and taking medications); 5.6. Severe cerebrovascular disease (CVA occurs multiple times or CVA has occurred in the past 6 months); 6. Prostate resection, pelvic radiotherapy history of any other malignancy, brachytherapy, cryotherapy, ultrasound-guided HIFU, testicular resection, photodynamic therapy, or prostate cancer-specific chemotherapy history; 7. Patients who have been treated with androgen blockade (ADT), alpha reductase inhibitors and / or other hormones in the past 6 months; 8. Any rectal disease, pathologic abnormality, injury, previous treatment or scar may alter the acoustic properties of the rectal wall or interfere with the insertion safety of the probe (e.g., inflammatory bowel disease, fistula, stenosis, fibrosis or symptomatic Of hemorrhoids); 9. History of invasive malignant tumors other than basal cell carcinoma or squamous skin cancer over the past 5 years; 10. There is urethral or bladder neck contracture / stenosis; 11. Patients with baseline urinary incontinence symptoms, defined as ICIQ-UI-SF questionnaire score> 3; 12. Active urinary tract infection; 13. Prostatitis NIH grades I, II and III; 14. There are implants close to the prostate (<1cm); 15. Because of the detection of cancerous lesions near the urethral sphincter or bladder neck, in the treatment can not completely avoid damage to it; 16. There are 2 mm or more calcification points near the rectal wall (less than 5 mm from the rectal wall), potentially interfering with the beam path; 17. There are fertility plans; 18. Other clinical trials currently involved in medical devices or medications, or have participated in such studies within 30 days prior to trial enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ablation area; | — |
Countries
China
Contacts
Public ContactLi Kangan
Shanghai General Hospital
Outcome results
None listed