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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 3

Conditions: Prostate Cancer

Treatments: Device: NanoKnife System; Radiation: Stereotactic Body Radiation Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07548164

26-029 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 224 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

IRE Boost Arm

Experimental group

Description:

Participants will receive Irreversible Electroporation

Treatment:

Radiation: Stereotactic Body Radiation Therapy

Device: NanoKnife System

RT Boost Arm

Active Comparator group

Description:

Participants will receive Radiation Therapy and will serve as the control arm

Treatment:

Radiation: Stereotactic Body Radiation Therapy