NanoKnife System
DeviceThe NanoKnife System is the device that is used for Irreversible Electroporation/IRE. The NanoKnife Generator is a microprocessor-controlled low energy direct current (LEDC) irreversible electroporation device.
NCT Number: NCT07548164
In this study the investigators will find out whether the use of a new type of boost approach called irreversible electroporation (IRE) is as effective as the standard boost approach of radiation therapy for participants with intermediate-risk prostate cancer receiving standard stereotactic body radiotherapy (SBRT).
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Interventional
Phase 3
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The NanoKnife System is the device that is used for Irreversible Electroporation/IRE. The NanoKnife Generator is a microprocessor-controlled low energy direct current (LEDC) irreversible electroporation device.
Radiation-based treatment intensification involves delivery of a boost to the dominant intraprostatic lesion (DIL) to a higher dose than the surrounding prostate tissue using external beam radiation therapy.
Other names: SBRT
Time frame: 2 years
The primary objective is to demonstrate that Irreversible Electroporation/IRE boost is non-inferior with respect to negative biopsy rate at 2 years compared to Radiation Therapy/RT boost. This is measured by the two-year biopsy negative rate for the control group and the intervention group.
Contact information is provided by the study sponsor or research team.
Himanshu Nagar, MD
CONTACT
Jonathan Fainberg, MD, MPH
CONTACT
Memorial Sloan Kettering Cancer Center
Other
Alternative Boost Approaches in Radiation Therapy IRreversible Electroporation Versus RADIAtioN BoosT for Intermediate Risk Prostate Cancer (IRRADIANT)
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