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Applying the steep pulse to treat the patients with Prostate cancer

Steep Pulse Device

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.

The Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Ablation Therapy

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

evaluation of pathological analysis from the biopsy sample to confirm if there remain clinically significant prostate cancer

evaluation of ablation range from prostate MRI to confirm if there remain suspicious lesions

evaluation of urination function by IPSS scoring

evaluation of sexual function by IIEF-5 scoring

Record of urinary catheter retention time

RenJi Hospital

Peking Union Medical College Hospital

Zhejiang University

Second Military Medical University

director, head of uroglogy department, clinical professor

steep pulse device

yinghao sun, MD,PHD

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.

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

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

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.

Persentage of normal glandular tissue in the specified targeted ablation zone by histopathology assessment

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)

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Ablation Therapy	NCT03838432	Prostate Cancer	Steep Pulse Dev...	40 Years - 85 Years	Second Military Medical University
The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal Therapy	NCT03315585	Prostate Cancer	steep pulse dev...	30 Years - 75 Years	Second Military Medical University

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