Alternative Boost Approaches in Radiation Therapy IRreversible Electroporation Versus RADIAtioN BoosT for Intermediate Risk Prostate Cancer (IRRADIANT)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device, Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Male
Healthy Volunteers: f
View:
• 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
Locations
United States
New Jersey
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
RECRUITING
New York
Weill Cornell Medical Center (Data Collection Only)
NOT_YET_RECRUITING
New York
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Himanshu Nagar, MD
nagarh1@mskcc.org
212-639-6478
Backup
Jonathan Fainberg, MD, MPH
fainberj@mskcc.org
646-422-4894
Time Frame
Start Date: 2026-04-16
Estimated Completion Date: 2029-04-16
Participants
Target number of participants: 224
Treatments
Experimental: IRE Boost Arm
Participants will receive Irreversible Electroporation
Active_comparator: RT Boost Arm
Participants will receive Radiation Therapy and will serve as the control arm
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center
Collaborators: Angiodynamics, Inc.