Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT07548164
This clinical trial evaluates the effectiveness of irreversible electroporation (IRE) using the NanoKnife System compared to standard radiation boost in intermediate-risk prostate cancer patients. Eligible participants must have specific cancer grades, gland size ≤ 80 cc, and meet MRI and IPSS criteria. The study involves using IRE and SBRT to target the dominant intraprostatic lesion.
Patient Parameters
| Parameter | Options |
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Program Overview
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 Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering at Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering at Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Weill Cornell Medical Center (Data Collection Only) | 10021 | New York | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | 10065 | New York | New York |
| Memorial Sloan Kettering at Nassau (Limited Protocol Activities) | 11553 | Uniondale | New York |
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