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

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Steep Pulse Device

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(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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Changhai Hospital,Second Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. The therapy must be thoroughtly understood with the agreement signed
2. Prostate MRI can identify negative extracapsular extension and seminal vesicle involvement,and no evidence of lymphatic metastasis
3. Patients must have confirmed prostate cancer by prostate maping biopsy
4. Low-risk or intermediate risk prostate cancer(PSA<20ng/ml,T1a-T2c,Gleason Score≤7)
5. There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
6. No prostatic calculus or prostatic calculus≤5mm
7. Age ≥ 40 - ≤ 85 years
8. Life expectancy of greater than 5 years(WHO Performance Status 0-1)
9. Patients with fertility are willing to take contraceptive measures until the end of the trial

Exclusion Criteria:

1. Patients have previously undergone radical prostatectomy, hormonal therapy or radiotherapy.
2. Patients underwent other surgery before less than 3 months.
3. Patients required long-term medication with anticoagulans or stop taking anticoagulans less than 1 months
4. Patients with clinically significant cardiovascular disease or other serious diseases
5. Patients with metal implants in their bodys(for example,cardiac pacemaker ) and/or with metal implants which located in the range from the first lumbar vertebra(L1) to the middle of femurs.
6. Patients with history of epilepsy
7. Patients with other malignant tumor or patients with hiv.
8. Patients with other serious systemic diseases that the study believes may interfere with the treatment, evaluation, and compliance of the trial;
9. Patients with participation in another clinical trial less than 3 months.
10. Patients with the judge that they are not suitable for this clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Steep Pulse Device; Applying the steep pulse to treat the patients with Prostate cancer	Device: Steep Pulse Device; Applying the steep pulse to treat the patients with Prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The result of prostate maping biopsy	evaluation of pathological analysis from the biopsy sample to confirm if there remain clinically significant prostate cancer	6 Months
The result of prostate MRI	evaluation of ablation range from prostate MRI to confirm if there remain suspicious lesions	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urinary incontinence	The rate of urinary incontinence	6 Months
urination function(IPSS scoring)	evaluation of urination function by IPSS scoring	6 Months
sexual function (IIEF-5 scoring)	evaluation of sexual function by IIEF-5 scoring	6 Months
urinary catheter retention time	Record of urinary catheter retention time	6 Months

Collaborators and Investigators

• Sponsor: Second Military Medical University
• Collaborators: Peking Union Medical College Hospital; RenJi Hospital; Zhejiang University

Publications and helpful links

General Publications

• Wang H, Xue W, Yan W, Yin L, Dong B, He B, Yu Y, Shi W, Zhou Z, Lin H, Zhou Y, Wang Y, Shi Z, Ren S, Gao X, Wang L, Xu C. Extended Focal Ablation of Localized Prostate Cancer With High-Frequency Irreversible Electroporation: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Aug 1;157(8):693-700. doi: 10.1001/jamasurg.2022.2230.
• He BM, Xue W, Yan WG, Yin L, Dong BJ, Zhou ZE, Lin HZ, Zhou Y, Wang YQ, Shi ZK, Zhou H, Wang SD, Ren SC, Gao X, Wang LH, Xu CL, Wang HF. A Multicenter Single-Arm Objective Performance Criteria Trial to Determine the Efficacy and Safety of High-Frequency Irreversible Electroporation as Primary Treatment for Localized Prostate Cancer: A Study Protocol. Front Oncol. 2021 Nov 10;11:760003. doi: 10.3389/fonc.2021.760003. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2018
• Primary Completion (ACTUAL): September 27, 2019
• Study Completion (ANTICIPATED): January 18, 2020

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: February 9, 2019
• First Posted (ACTUAL): February 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 14, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: prostate cancer; Multi-center; IRE; focal therapy; Composite Steep-pulse Treatment Apparatus
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: BZLC-12-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No