Status:
UNKNOWN
The Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Ablation Therapy
Lead Sponsor:
Second Military Medical University
Collaborating Sponsors:
RenJi Hospital
Peking Union Medical College Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
40-85 years
Phase:
NA
Brief Summary
This trial is studying the effects and safety in treating patients from five different centers with local prostate cancer, employing Composite Steep-pulse(High-frequency irreversible electroporation) ...
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
- The therapy must be thoroughtly understood with the agreement signed
- Prostate MRI can identify negative extracapsular extension and seminal vesicle involvement,and no evidence of lymphatic metastasis
- Patients must have confirmed prostate cancer by prostate maping biopsy
- Low-risk or intermediate risk prostate cancer(PSA\<20ng/ml,T1a-T2c,Gleason Score≤7)
- There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
- No prostatic calculus or prostatic calculus≤5mm
- Age ≥ 40 - ≤ 85 years
- Life expectancy of greater than 5 years(WHO Performance Status 0-1)
- Patients with fertility are willing to take contraceptive measures until the end of the trial
Exclusion
- Patients have previously undergone radical prostatectomy, hormonal therapy or radiotherapy.
- Patients underwent other surgery before less than 3 months.
- Patients required long-term medication with anticoagulans or stop taking anticoagulans less than 1 months
- Patients with clinically significant cardiovascular disease or other serious diseases
- Patients with metal implants in their bodys(for example,cardiac pacemaker ) and/or with metal implants which located in the range from the first lumbar vertebra(L1) to the middle of femurs.
- Patients with history of epilepsy
- Patients with other malignant tumor or patients with hiv.
- Patients with other serious systemic diseases that the study believes may interfere with the treatment, evaluation, and compliance of the trial;
- Patients with participation in another clinical trial less than 3 months.
- Patients with the judge that they are not suitable for this clinical trial
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2020
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03838432
Start Date
May 2 2018
End Date
January 18 2020
Last Update
December 17 2019
Active Locations (1)
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1
Changhai Hospital,Second Military Medical University
Shanghai, Shanghai Municipality, China, 200000