Prostate Cancer Clinical Trial
Official title:
The Efficacy and Safety of Composite Steep-pulse(High-frequency Irreversible Electroporation) Treatment Apparatus Used in Prostate Cancer Ablation Therapy : a Multicenter, Single-arm, Objective Performance Criteria Trial
Verified date | December 2019 |
Source | Second Military Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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) Treatment Apparatus. This device could cause cell irreversible electroporation, which leading necrosis of tumor cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and histopathological analysis of prostate speciem will be evaluated in each study patients.
Status | Active, not recruiting |
Enrollment | 119 |
Est. completion date | January 18, 2020 |
Est. primary completion date | September 27, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. The therapy must be thoroughtly understood with the agreement signed 2. Prostate MRI can identify negative extracapsular extension and seminal vesicle involvement,and no evidence of lymphatic metastasis 3. Patients must have confirmed prostate cancer by prostate maping biopsy 4. Low-risk or intermediate risk prostate cancer(PSA<20ng/ml,T1a-T2c,Gleason Score=7) 5. There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI 6. No prostatic calculus or prostatic calculus=5mm 7. Age = 40 - = 85 years 8. Life expectancy of greater than 5 years(WHO Performance Status 0-1) 9. Patients with fertility are willing to take contraceptive measures until the end of the trial Exclusion Criteria: 1. Patients have previously undergone radical prostatectomy, hormonal therapy or radiotherapy. 2. Patients underwent other surgery before less than 3 months. 3. Patients required long-term medication with anticoagulans or stop taking anticoagulans less than 1 months 4. Patients with clinically significant cardiovascular disease or other serious diseases 5. 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. 6. Patients with history of epilepsy 7. Patients with other malignant tumor or patients with hiv. 8. Patients with other serious systemic diseases that the study believes may interfere with the treatment, evaluation, and compliance of the trial; 9. Patients with participation in another clinical trial less than 3 months. 10. Patients with the judge that they are not suitable for this clinical trial |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital,Second Military Medical University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Second Military Medical University | Peking Union Medical College Hospital, RenJi Hospital, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The result of prostate maping biopsy | evaluation of pathological analysis from the biopsy sample to confirm if there remain clinically significant prostate cancer | 6 Months | |
Primary | The result of prostate MRI | evaluation of ablation range from prostate MRI to confirm if there remain suspicious lesions | 6 Months | |
Secondary | urinary incontinence | The rate of urinary incontinence | 6 Months | |
Secondary | urination function(IPSS scoring) | evaluation of urination function by IPSS scoring | 6 Months | |
Secondary | sexual function (IIEF-5 scoring) | evaluation of sexual function by IIEF-5 scoring | 6 Months | |
Secondary | urinary catheter retention time | Record of urinary catheter retention time | 6 Months |
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