Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer
Status and phase
Enrolling
Phase 3
Conditions
Prostate Cancer
Treatments
Device: NanoKnife System
Radiation: Stereotactic Body Radiation Therapy
Details and patient eligibility
About
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).
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)
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
Trial contacts and locations
8
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Central trial contact
Himanshu Nagar, MD; Jonathan Fainberg, MD, MPH
Data sourced from clinicaltrials.gov
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