NCT07548164招募中3 期
Alternative Boost Approaches in Radiation Therapy IRreversible Electroporation Versus RADIAtioN BoosT for Intermediate Risk Prostate Cancer (IRRADIANT)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 224
- 试验地点
- 8
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IRE Boost Arm
Experimental
Participants will receive Irreversible Electroporation
干预措施: Stereotactic Body Radiation Therapy (Radiation)
IRE Boost Arm
Experimental
Participants will receive Irreversible Electroporation
干预措施: NanoKnife System (Device)
RT Boost Arm
Active Comparator
Participants will receive Radiation Therapy and will serve as the control arm
干预措施: Stereotactic Body Radiation Therapy (Radiation)
研究者
研究点 (8)
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