Alternative Boost Approaches in Radiation Therapy IRreversible Electroporation Versus RADIAtioN BoosT for Intermediate Risk Prostate Cancer (IRRADIANT)
Memorial Sloan Kettering Cancer Center
Summary
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).
Eligibility
- Age range
- Not specified
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Biopsy proven grade group 2 or 3 (GS 3+4 or GS 4+3) cancer with all pattern 4 found only in the MRI target * Gland size ≤ 80 cc * Prostate MRI \< rT3b disease * IPSS \< 20 * No contraindication to IRE, RT, anesthesia, or transperineal procedure Exclusion Criteria: * Any Grade Group ≥4 disease, or any cribriform and/or intraductal carcinoma * Evidence of nodal or /metastatic disease on MRI and/or PSMA PET/CT * Unfit for general anesthesia, or contraindication/hypersensitivity to required neuromuscular blocking agents * Active urinary tract infection (UTI) at the time of…
Interventions
- DeviceNanoKnife System
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.
- RadiationStereotactic Body Radiation Therapy
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.
Locations (8)
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering at Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering at Westchester (Limited Protocol Activities)Harrison, New York
- Weill Cornell Medical Center (Data Collection Only)New York, New York