An interventional study of Focal irreversible electroporation of the prostate cancer in Prostate Cancer and Prostate Adenocarcinoma, sponsored by I.M. Sechenov First Moscow State Medical University. Completed at 1 site in Russian Federation. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-28.
Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment
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.
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).
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 10 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
PSA level
Stable decrese of PSA level after surgery (\<1 ng/ml)
Time frame: 3 months, 6 months, 9 months, 12 months.
Complications
Short and long term surgical complications
Time frame: 1 year
IPSS (International Prostate Symptom Score, range from 5 to 30)
International Prostate Symptom Score
Time frame: 1 year
QoL (Quality of Life score, range 1-6)
Quality of Life Score
Time frame: 1 year
Qmax
Maximal urine flow rate
Time frame: 1 year
IIEF
International Index of Erectile Function - Erectile function assessment (range 1-5)
Time frame: 1 year
Plan to share: Undecided
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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I.M. Sechenov First Moscow State Medical University