Status:
COMPLETED
The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal Therapy
Lead Sponsor:
Second Military Medical University
Conditions:
Prostate Cancer
Eligibility:
MALE
30-75 years
Phase:
NA
Brief Summary
This trial is studying the effects and safety in treating patients with local prostate cancer with a new IRE device called Composite Steep-pulse Treatment Apparatus. This new device could cause cell i...
Detailed Description
Background: Prostate cancer is the most common cancer in elderly males in western country. It is also a major health concern, especially in China with its greater proportion of elderly men in the gen...
Eligibility Criteria
Inclusion
- Prostate MRI can identify the suspect region(pi-RADS≥4 ) ,and no evidence of lymphatic metastasis
- Patients must have confirmed prostate cancer by prostate biopsy
- There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
- No prostatic calculus or prostatic calculus≤5mm
- No contraindication on total intravenous anesthesia
- Not take any anticoagulants before or discontinue anticoagulant therapy at least 7 days
- Age ≥ 30 - ≤ 75 years
- Life expectancy of greater than 10 years
- Patients scheduled for radical prostatectomy.
- Sexually potent
Exclusion
- Patients have previously undergone radical prostatectomy.
- Patients have previously undergone hormonal therapy or radiotherapy.
- Patients underwent other surgery before less than 3 months
- Clinically significant cardiovascular disease
- Patients with other malignant tumor or patients with hiv.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with poor health condition
- Simultaneous participation in another clinical trial
Key Trial Info
Start Date :
April 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03315585
Start Date
April 27 2017
End Date
October 27 2017
Last Update
April 13 2018
Active Locations (1)
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1
Changhai Hospital,Second Military Medical University
Shanghai, Shanghai Municipality, China, 200000