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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
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.
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
RECRUITINGBiopsy negative rate at 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.
Time frame: 2 years
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Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, United States
RECRUITINGWeill Cornell Medical Center (Data Collection Only)
New York, New York, United States
NOT_YET_RECRUITINGMemorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States
RECRUITINGMemorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, United States
RECRUITING