The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): steep pulse device
Intervention type(s): Device
Intervention description(s): Applying the steep pulse to treat the patients with Prostate cancer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: focal therapy; IRE; Composite Steep-pulse Treatment Apparatus; prostate cancer