Prostate Cancer Clinical Trial
Official title:
The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal therapy-a Phase I Study
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.
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:
1. This study will assess the efficacy of Composite Steep-pulse Treatment Apparatus in the
treatment of PCa.
2. This study will assess potency, urinary continence and complication rate for the
patients undergo the treatment with steep pulse device.
3. Histopathological analysis of prostate speciem 4 weeks after treated by Composite
Steep-pulse Treatment Apparatus.
Methods:
1. patients recruitment
2. transperineal prostate targeted biopsy guided by multiparametric magnetic resonance
imaging/transrectal ultrasound (mpMRI/TRUS) fusion, plus systemic prostate biopsy.
3. Frozen pathological analysis will be performed;
4. Irreversible Electroporation of malignant Tumor Cell under Composite Steep-pulse
Treatment for the patients with positive biopsy;
5. Complication, urinary continence, and sexual function will be evaluated after the IRE
treatment;
6. RP for these patients in 4 weeks after the treatment of Composite Steep-pulse Treatment.
7. Histopathological Outcomes analysis will be performed to evaluate tumor residual rate,
urethral injuries, nerve injuries and capsule injury in and beside the ablation area.
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