The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal Therapy

Study Overview
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Brief Summary
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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 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.

Detailed Description
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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 general population. Currently, radical prostatectomy(RP) is the mainstream treatment for localized PCa to show a benefit for cancer-specific survival (CSS). However, the patient who underwent RP might suffer from the complication of erectile dysfunction or urinary incontinence. In 2004, a new method using steep pulses to treat tumor was appeared. It showed that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading tonecrosis of tumor cells. And it seemed to do no harms to the nerve and Vascular epithelial cell. The device of steep pulse had already been approved by FDA in 2011.However, this device of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury; (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite Steep-pulse Treatment Apparatus, may have the potential to conquer these disadvantages. Purpose: This study will assess the efficacy of Composite Steep-pulse Treatment Apparatus in the treatment of PCa. This study will assess potency, urinary continence and complication rate for the patients undergo the treatment with steep pulse device. Histopathological analysis of prostate speciem 4 weeks after treated by Composite Steep-pulse Treatment Apparatus. Methods: patients recruitment transperineal prostate targeted biopsy guided by multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion, plus systemic prostate biopsy. Frozen pathological analysis will be performed; Irreversible Electroporation of malignant Tumor Cell under Composite Steep-pulse Treatment for the patients with positive biopsy; Complication, urinary continence, and sexual function will be evaluated after the IRE treatment; RP for these patients in 4 weeks after the treatment of Composite Steep-pulse Treatment. Histopathological Outcomes analysis will be performed to evaluate tumor residual rate, urethral injuries, nerve injuries and capsule injury in and beside the ablation area.

Official Title
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The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal therapy-a Phase I Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: steep pulse device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steep Pulse Device<br>Applying the steep pulse to treat the patients with Prostate cancer | Device: steep pulse device<br>* Applying the steep pulse to treat the patients with Prostate cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure | To determine if the IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma. | 1 Year | 
| Efficacy (persentage of unablated tissue un the ablation zone) | Persentage of normal glandular tissue in the specified targeted ablation zone by histopathology assessment | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual function | Mean sexual function domain score (IIEF-5 scoring: The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction) | 1 month | 
| Urinary incontinence | Mean urinary incontinence domain score (the number of pad everyday,good is less than 2 pads a day, more or equal than 2 pads a day) | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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focal therapy, IRE, Composite Steep-pulse Treatment Apparatus, prostate cancer