Dysautonomia International

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

Purpose

In this study we 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 people with intermediate-risk prostate cancer receiving standard stereotactic body radiotherapy (SBRT).

Condition

Prostate Cancer

Eligibility

Eligible Ages: Between 18 Years and 99 Years
Eligible Sex: Male
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental IRE Boost Arm	Participants will receive Irreversible Electroporation	Device: NanoKnife System 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. Radiation: Stereotactic Body Radiation Therapy 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. Other names: SBRT
Active Comparator RT Boost Arm	Participants will receive Radiation Therapy and will serve as the control arm	Radiation: Stereotactic Body Radiation Therapy 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. Other names: SBRT

Recruiting Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920