Clinical trial NCT03504995: Efficacy and Safety Assessment of IRE of Localized Prostate Cancer.
Official title: Efficacy and Safety Assessment of Nanoknife (AngyoDynamics, USA) for Irreversible Electroporation (IRE) of Localized Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Keywords: Prostate
Irreversible Electroporation
Prostate Cancer
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: PSA level
timeFrame: 3 months, 6 months, 9 months, 12 months.
measure: Complications
timeFrame: 1 year
Secondary outcomes:
measure: IPSS (International Prostate Symptom Score, range from 5 to 30)
timeFrame: 1 year
measure: QoL (Quality of Life score, range 1-6)
timeFrame: 1 year
measure: Qmax
timeFrame: 1 year
measure: IIEF
timeFrame: 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of Urology, Sechenov University
Study officials:
affiliation: I.M. Sechenov First Moscow State Medcal University
name: Dmitry Enikeev, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Rubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. doi: 10.1177/153303460700600401.
citation: Scheltema MJ, Chang JI, Bohm M, van den Bos W, Blazevski A, Gielchinsky I, Kalsbeek AMF, van Leeuwen PJ, Nguyen TV, de Reijke TM, Siriwardana AR, Thompson JE, de la Rosette JJ, Stricker PD. Pair-matched patient-reported quality of life and early oncological control following focal irreversible electroporation versus robot-assisted radical prostatectomy. World J Urol. 2018 Sep;36(9):1383-1389. doi: 10.1007/s00345-018-2281-z. Epub 2018 Mar 28.