NCT07548164PHASE3Recruiting
Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer
Memorial Sloan Kettering Cancer Center
Start Date
4/16/2026
Completion Date
4/16/2029
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 Criteria
Age Range: No minimum to No maximum
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; systematic biopsy pattern 4 that is concordant with MRI target per investigator is permissible
* 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 IRE or biopsy; must be treated and resolved prior to proceeding
* Actively bleeding, known bleeding disorder, or inability to interrupt anticoagulants/antiplatelet therapy as clinically indicated for biopsy/IRE safety
* Any history of cardiac arrhythmia or epilepsy, or recent myocardial infarction, consistent with NanoKnife contraindication statements
* Presence of an implanted pacemaker/defibrillator or other active implanted electronic device, or other device-related contraindications per current NanoKnife labeling/user manual
* Inability to undergo pelvic MRI
* Prior treatment of prostate cancer including androgen deprivation therapy, focal therapy, radiation therapy, or prostatectomy
* Current or intended use of androgen deprivation therapy
Interventions
DEVICE
NanoKnife System
RADIATION
Stereotactic Body Radiation Therapy
Conditions
Prostate Cancer
Locations
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York 11725
United States
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York 10604
United States
Weill Cornell Medical Center (Data Collection Only)
New York, New York 10021
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York 10065
United States
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York 11553
United States