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Efficacy and Safety Assessment of IRE of Localized Prostate Cancer.

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ClinicalTrials.gov Identifier: NCT03504995
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University

Brief Summary:

The purpose of this study is to evaluate safety and short-term oncological efficacy of the NanoKnife Irreversible Electroporation System for localised prostate cancer.

Irreversible electroporation (IRE) is the method of focal treatment for prostate cancer, which is already proven by FDA as method of the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.


Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Adenocarcinoma Device: Focal irreversible electroporation of the prostate cancer Not Applicable

Detailed Description:

Irreversible electroporation is a newly developed non-thermal tissue ablation technique in which short duration electrical fields are used to form permanent nanoscale defects in the cell membrane which leads to cell apoptosis. Thus, IRE is a non-thermal technique, which means that changes associated with tissue freezing or heating are not relevant.

Moreover, animal studies of IRE in the canine prostate have demonstrated that structures such as ejaculatory ducts, neurovascular bundles, blood vessels, and the urethra heal normally after ablation. The reason is that collagen matrix during treatment with IRE is not destroyed thus allowing for a large structures (blood vessels, nerves, etc.) to heal normally.

This study is a prospective and non-randomized with one group of 10 patients eligible for focal therapy of prostate cancer with IRE (eligibility defined by this protocol).

Before the surgery all patients will underwent transperineal MRI-fusion biopsy to localize the prostate cancer foci.

Objectives of the study: to asses safety of IRE in patients with localized PCa, to asses short-term oncologic efficacy of IRE in patients with localized PCa, to asses functional outcomes after IRE.

All patients will be followed up for 1 year (each 3 months).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Assessment of Nanoknife (AngyoDynamics, USA) for Irreversible Electroporation (IRE) of Localized Prostate Cancer.
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: IRE patients
patients who will underwent 'Focal irreversible electroporation of the prostate cancer'
Device: Focal irreversible electroporation of the prostate cancer
Irreversible electroporation is a non-thermal tissue ablation technique in which short duration electrical fields are used to permanently permeabilize the cell membrane.




Primary Outcome Measures :
  1. PSA level [ Time Frame: 3 months, 6 months, 9 months, 12 months. ]
    Stable decrese of PSA level after surgery (<1 ng/ml)

  2. Complications [ Time Frame: 1 year ]
    Short and long term surgical complications


Secondary Outcome Measures :
  1. IPSS (International Prostate Symptom Score, range from 5 to 30) [ Time Frame: 1 year ]
    International Prostate Symptom Score

  2. QoL (Quality of Life score, range 1-6) [ Time Frame: 1 year ]
    Quality of Life Score

  3. Qmax [ Time Frame: 1 year ]
    Maximal urine flow rate

  4. IIEF [ Time Frame: 1 year ]
    International Index of Erectile Function - Erectile function assessment (range 1-5)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Verified with MR-fusion biopsy localized Pca
  • PSA < 15 ng/ml
  • Gleason score 3+3=6; 3+4=7 OR Grade Group 1 and 2
  • Life expectancy > 10 years
  • No post-void residual urine or infravesical obstruction

Exclusion Criteria:

  • patients with artificial cardiac pacemaker
  • patients without rectum
  • patients not eligible for general anesthesia
  • PIRADS<3
  • patients after primary Pca treatment
  • hormonal therapy six months before the study
  • radiotherapy of pelvic organs
  • urinary infection
  • extracapsular Pca
  • patients with metastatic lesions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504995


Contacts
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Contact: Dmitry Enikeev, MD, PhD +7 925 517 79 26 enikeev-dv@1msmu.ru

Locations
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Russian Federation
Clinic of Urology, Sechenov University Recruiting
Moscow, Russian Federation, 119991
Contact: Dmitry Enikeev, MD, PhD    +7 925 517 79 26    enikeev-dv@1msmu.ru   
Sponsors and Collaborators
I.M. Sechenov First Moscow State Medical University
Investigators
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Study Director: Dmitry Enikeev, MD, PhD I.M. Sechenov First Moscow State Medcal University

Publications:
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Responsible Party: Dmitry Enikeev, MD, PhD, Deputy Director for Science of RI of Uronephrology and Reproductive Health, I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier: NCT03504995     History of Changes
Other Study ID Numbers: Sechenov-IRE18
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University:
Prostate
Irreversible Electroporation
Prostate Cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Genital Diseases, Male
Carcinoma