Irreversible Electroporation(IRE) For Unresectable Prostatic Neoplasms

NCT02430649 | Withdrawn DMC

• 1 other identifier: Prostatic Neoplasms-IRE-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Prostatic Neoplasms.

Conditions

Prostatic Neoplasms

Keywords

irreversible electroporation; Unresectable Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse events

  6 month

Secondary Outcomes (4)

• Percentage of lesions that show no sign of recurrence 12 months after IRE

  12 months

• Voltage (A minimum and maximum range of voltage for safe and effective IRE)

  3 months

• Progress free disease (PFS)

  12 months

• Overall survival (OS)

  36 months

Study Arms (2)

IRE Group

EXPERIMENTAL

irreversible electroporation for Unresectable Prostatic Neoplasms

Procedure: Irreversible electroporation (IRE); Device: NanoKnife

Control

NO INTERVENTION

The patients without treatment

Interventions

Irreversible electroporation (IRE) PROCEDURE

Also known as: NanoKnife

IRE Group

NanoKnife DEVICE

IRE Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostatic Neoplasms diagnosed by positive biopsy or non-invasive criteria,
• Not suitable for surgical resection,
• Eastern Cooperative Oncology Group (ECOG) score of 0-1,
• A prothrombin time ratio \> 50%,
• Platelet count \> 80x10\^9/L,
• Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
• Able to comprehend and willing to sign the written informed consent form (ICF),
• Have a life expectancy of at least 3 months.

You may not qualify if:

• Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
• Any active implanted device (eg Pacemaker),
• Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
• Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
• Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Lizhi Niu, PhD

  Fuda Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2015
• First Posted: April 30, 2015
• Study Start: January 1, 2015
• Primary Completion: May 20, 2020
• Study Completion: January 1, 2025
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

CN (1)