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

RecruitingPhase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Conditions: Prostate Cancer

Interventions: NanoKnife System, Stereotactic Body Radiation Therapy

Countries: United States

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 overview

Sex: MALE

Healthy volunteers: No

Study type: INTERVENTIONAL

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; 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

Locations (8)

Basking Ridge, New Jersey, United States
Middletown, New Jersey, United States
Montvale, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
New York, New York, United States
New York, New York, United States
Uniondale, New York, United States