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Irreversible Electroporation Boost Approach versus Standard Radiation Boost for the Treatment of Intermediate Risk Prostate Cancer, IRRADIANT Trial
Trial Status: active
This clinical trial compares the effect of two different radiation boost approaches, irreversible electroporation (IRE) using the NanoKnife System and a standard radiation boost, in combination with standard of care stereotactic body radiotherapy (SBRT) in treating patients with prostate cancer that may be less likely to get worse, or progress, than high-risk cancers (intermediate risk). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. A radiation boost is one or more extra radiation treatments targeted at the tumor bed. A standard radiation therapy boost involves delivering more intense radiation therapy to the part of the prostate with the tumor. IRE is a different type of boost that delivers electrical energy between needles placed in a tumor. The electrical energy causes cells to die. The NanoKnife System is the device used to deliver IRE. It consists of the needles that are placed in the tumor and the mechanical equipment needed to create the electrical energy. IRE works in combination with a lower dose of radiation therapy. Giving an IRE boost with a lower dose of SBRT may be safe, tolerable, and more effective than a standard dose of SBRT with a standard boost in treating patients with intermediate risk prostate cancer.
Inclusion Criteria
Biopsy proven grade group 2 or 3 (Gleason score [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 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07548164.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Himanshu Nagar
Phone: 212-639-6478
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Himanshu Nagar
Phone: 212-639-6478
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Himanshu Nagar
Phone: 212-639-6478
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Himanshu Nagar
Phone: 212-639-6478
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Himanshu Nagar
Phone: 212-639-6478
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Himanshu Nagar
Phone: 212-639-6478
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Himanshu Nagar
Phone: 212-639-6478
PRIMARY OBJECTIVE:
I. To demonstrate that IRE boost has a non-inferior negative biopsy rate at 2 years compared to radiation therapy (RT) boost.
SECONDARY OBJECTIVES:
I. Compare biochemical progression free survival (bPFS), metastasis free survival (MFS), and overall survival (OS) between arms.
II. Compare patient-reported gastrointestinal (GI) function using the Expanded Prostate Cancer Index Composite-Bowel Domain (EPIC-BA) at baseline, 3, 6, 12, and 24 months from end of RT.
III. Compare patient-reported genitourinary (GU) function using the International Prostate Symptom Score (IPSS) at baseline, 3, 6, 12, and 24 months from end of RT.
IV. Compare patient-reported erectile and ejaculation symptoms using the International Index of Erectile Function (IIEF)-6 and Male Sexual Health Questionnaire - Ejaculatory Dysfunction Short Form (MSHQ-EjD) at baseline, 3, 6, 12, and 24 months from end of RT.
EXPLORATORY OBJECTIVES:
I. Compare pre- and post-intervention prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) and magnetic resonance imaging (MRI) per subject at 2 years.
II. Imaging and paraffin-embedded tissue block, serum, plasma, whole blood, and urine will be collected for future translational research analyses through a separate biospecimen research protocol (BRP) for predictors of efficacy and toxicity.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo IRE boost delivered with NanoKnife System followed by lower dose SBRT every other day (QOD) for up to a total of 5 treatments over 15 days in the absence of disease progression or unacceptable toxicity. Patients also undergo urine and blood sample collection, prostate MRI, and prostate biopsy throughout the study. Additionally, patients may optionally undergo PSMA PET/CT throughout the study.
ARM II: Patients undergo standard dose SBRT QOD for up to a total of 5 treatments over 15 days with standard radiation therapy boost in the absence of disease progression or unacceptable toxicity. Patients also undergo urine and blood sample collection, prostate MRI, and prostate biopsy throughout the study. Additionally, patients may optionally undergo PSMA PET/CT throughout the study.
After completion of study treatment, patients are followed up at 4 weeks and at 3, 6, 12, 24, and 36 months, then annually through year 5.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
