Irreversible electroporation (IRE) versus standard radiation boost for intermediate-risk prostate cancer
Alternative Boost Approaches in Radiation Therapy IRreversible Electroporation Versus RADIAtioN BoosT for Intermediate Risk Prostate Cancer (IRRADIANT)
The trial will test whether adding an irreversible electroporation (IRE) boost works as well as the standard radiation boost for people with intermediate-risk prostate cancer receiving SBRT.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Sex | Male |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Trial ID | NCT07548164 on ClinicalTrials.gov |
What this trial studies
Participants with intermediate-risk prostate cancer (grade group 2 or 3, gland ≤80 cc, MRI-confined disease) receive standard stereotactic body radiotherapy (SBRT) and are assigned to either a focal IRE boost using the NanoKnife system or the standard radiation boost. The comparison focuses on cancer control, urinary and sexual function, and treatment-related side effects measured by PSA, imaging, and patient-reported outcomes. Procedures include transperineal IRE under general anesthesia, SBRT delivery, and scheduled follow-up visits with PSA and MRI as indicated. Safety monitoring will track adverse events related to IRE, anesthesia, and radiation during and after treatment.
Who should consider this trial
Good fit: Ideal candidates are people with intermediate-risk prostate cancer (grade group 2 or 3) with all pattern 4 confined to the MRI target, prostate gland ≤80 cc, IPSS <20, and who can safely undergo general anesthesia, neuromuscular blockade, and a transperineal procedure.
Not a fit: Patients with grade group ≥4 disease or cribriform/intraductal carcinoma, nodal or metastatic disease, implanted pacemakers/defibrillators, certain cardiac arrhythmias or epilepsy, active UTI, bleeding disorders, or inability to undergo anesthesia or interrupt anticoagulation are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the IRE boost could provide similar or improved tumor control with potentially less damage to surrounding tissue and better urinary or sexual function.
How similar studies have performed: Small pilot and single-center series of focal IRE in prostate cancer have shown promising local control and acceptable safety, but randomized phase 3 comparisons to standard radiation boosts are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Where this trial is running
Basking Ridge, New Jersey and 7 other locations
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering at Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering at Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Weill Cornell Medical Center (Data Collection Only) — New York, New York, United States (Not_yet_recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering at Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Himanshu Nagar, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Himanshu Nagar, MD
- Email: nagarh1@mskcc.org
- Phone: 212-639-6478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.