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

RECRUITINGPhase 3Sponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
PhasePhase 3
SponsorMemorial Sloan Kettering Cancer Center
Started2026-04-16
Est. completion2029-04-16
Eligibility
Age18 Years – 99 Years
SexMALE
Healthy vol.Accepted
Locations8 sites

Summary

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).

Eligibility

Age: 18 Years – 99 YearsSex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

Locations8 sites

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Himanshu Nagar, MD212-639-6478
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Himanshu Nagar, MD212-639-6478
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Himanshu Nagar, MD212-639-6478
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Himanshu Nagar, MD212-639-6478
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Himanshu Nagar, MD212-639-6478

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