Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07548164
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • NanoKnife System — DEVICE
    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.
  • Stereotactic Body Radiation Therapy — RADIATION
    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.

Study Details

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).

Key Dates

Start date
Apr 16, 2026
Status verified
May 2026
Primary completion
Apr 16, 2029
Completion
Apr 16, 2029

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Biopsy negative rate at 2 years [ Time Frame: 2 years ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Himanshu Nagar, MD
212-639-6478
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Himanshu Nagar, MD
212-639-6478
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Himanshu Nagar, MD
212-639-6478
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)CommackNew York11725
Himanshu Nagar, MD
212-639-6478
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)HarrisonNew York10604
Himanshu Nagar, MD
212-639-6478
Memorial Sloan Kettering Cancer Center (All Protocol Activites)New YorkNew York10065
Himanshu Nager, MD
212-639-6478
Weill Cornell Medical Center (Data Collection Only)New YorkNew York10021
Timothy McClure, MD, MS
646-962-6363
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)UniondaleNew York11553
Himanshu Nagar, MD
212-639-6478

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