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

NCT03315585 | Completed

• 1 other identifier: REMD-FA2017001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

focal therapy; IRE; Composite Steep-pulse Treatment Apparatus; prostate cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure

  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.

  1 Year

• Efficacy (persentage of unablated tissue un the ablation zone)

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

  1 month

Secondary Outcomes (2)

• Sexual function

  1 month

• Urinary incontinence

  1 month

Study Arms (1)

Steep Pulse Device

EXPERIMENTAL

Applying the steep pulse to treat the patients with Prostate cancer

Device: steep pulse device

Interventions

steep pulse device DEVICE

Applying the steep pulse to treat the patients with Prostate cancer

Steep Pulse Device

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate MRI can identify the suspect region(pi-RADS≥4 ) ,and no evidence of lymphatic metastasis
• Patients must have confirmed prostate cancer by prostate biopsy
• There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
• No prostatic calculus or prostatic calculus≤5mm
• No contraindication on total intravenous anesthesia
• Not take any anticoagulants before or discontinue anticoagulant therapy at least 7 days
• Age ≥ 30 - ≤ 75 years
• Life expectancy of greater than 10 years
• Patients scheduled for radical prostatectomy.
• Sexually potent

You may not qualify if:

• Patients have previously undergone radical prostatectomy.
• Patients have previously undergone hormonal therapy or radiotherapy.
• Patients underwent other surgery before less than 3 months
• Clinically significant cardiovascular disease
• Patients with other malignant tumor or patients with hiv.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with poor health condition
• Simultaneous participation in another clinical trial

Sponsors & Collaborators

• Second Military Medical University: lead

Study Sites (1)

Changhai Hospital,Second Military Medical University

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• yinghao sun, MD,PHD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director, head of uroglogy department, clinical professor

Study Record Dates

• First Submitted: July 2, 2017
• First Posted: October 20, 2017
• Study Start: April 27, 2017
• Primary Completion: October 27, 2017
• Study Completion: October 27, 2017
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

CN (1)