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
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.
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(High-frequency irreversible electroporation) Treatment Apparatus, may have the
potential to conquer these disadvantages.
Purpose:
1. This study will assess the efficacy of Composite Steep-pulse(High-frequency irreversible
electroporation) Treatment Apparatus in the treatment of PCa.
2. This study will assess the safety of Composite Steep-pulse(High-frequency irreversible
electroporation) Treatment Apparatus in the treatment of PCa.
Methods:
1. patients recruitment
2. transperineal maping prostate biopsy(>20 needle) guided by transrectal ultrasound(TRUS).
3. Irreversible Electroporation of malignant Tumor Cell under Composite Steep-pulse
Treatment for the patients with positive biopsy;
4. Some factors such as prostate MRI,the maping prostate biopsy(>20 needle),the
histopathological outcomes analysis ect. will be performed to evaluate the efficacy of
the treatment.
5. Other factors such as the routine blood test, the routine urine test, the urinary
continence ect. will be performed to evaluate the safety of the treatment.
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