Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer
Recruiting · NCT07548164 · Interventional (participants receive a specific treatment) · Lead sponsor: Memorial Sloan Kettering Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
NanoKnife SystemStereotactic Body Radiation Therapy
What this trial is 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).
Who can take part
Age range
No age limits stated
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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; systematic biopsy pattern 4 that is concordant with MRI target per investigator is permissible
- 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
Where it is running
8 locations listed across 2 US states.
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) - Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) - Middletown, New Jersey, United States
- Memorial Sloan Kettering at Bergen (Limited Protocol Activities) - Montvale, New Jersey, United States
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) - Commack, New York, United States
- Memorial Sloan Kettering at Westchester (Limited Protocol Activities) - Harrison, New York, United States
- Weill Cornell Medical Center (Data Collection Only) - New York, New York, United States
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) - New York, New York, United States
- Memorial Sloan Kettering at Nassau (Limited Protocol Activities) - Uniondale, New York, United States