Prostate Cancer IRE Study (PRIS) - A Randomized Controlled Trial Comparing Focal to Radical Treatment in Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Primary outcome in PRIS 2: Irritative urinary symptoms
研究概览
简要总结
The aim of this study is to evaluate the feasibility to treat localized prostate cancer diagnosed with MRI and targeted/systematic biopsies, with IRE in comparison with conventional radical treatments with the primary objective to locally control the tumour with a minimum of side effects.
详细描述
OBJECTIVES The aim of the proposed research is to evaluate the cancer control, genitourinary, rectal and overall health-related quality of life outcomes of focal therapy for unifocal localized prostate cancer using irreversible electroporation (IRE).
PRIMARY AIM
• To evaluate functional outcomes in men treated for unifocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy
SECONDARY AIMS
- To evaluate adverse events in men treated for unilfocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy
- To evaluate progression free and treatment free survival in men treated for unifocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy
- Economic evaluation of each technique
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
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age at inclusion ≥ 40 years
- •MRI-visible lesion
- •EPE 3* <1.5 cubic cm3 lesion volume
- •Gleason score 3 + 4 or 4 + 3 from a single MRI-visible lesion without any Gleason grade 4 in systematic biopsies outside of the target
- •PSA level ≤ 20 ng/ml
- •Clinical stage ≤ T2c disease
- •Unifocal significant disease
- •Life expectancy of ≥ 10 years
- •Sufficient proficiency in the Swedish language to understand written and verbal information about the trial, its consent process and the study questionnaires
- •Extraprostatic extension; 5-grade Likert scale 1=
排除标准
- •Intraductal tumour
- •History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment
- •History of cardiac arrythmias
- •Pacemaker
- •Renal insufficiency; GFR<30
- •Severe illnesses such as concomitant cancers, severe cardio-vascular disease or dementia
- •Contraindications for magnetic resonance imaging (MRI) e.g. magnetic cerebral clips, cochlear implants or severe claustrophobia
- •History of bladder cancer
- •History of previous pelvic radiotherapy
研究组 & 干预措施
PRIS 1, arm 1
Men randomized to the experimental arms will be offered focal treatment of prostate cancer with IRE technology. IRE stands for "irreversible electroporation" and involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death.
干预措施: Irreversible electroporation, IRE (Procedure)
PRIS 2, arm 1
Men randomized to the experimental arms will be offered focal treatment of prostate cancer with IRE technology. IRE stands for "irreversible electroporation" and involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death.
干预措施: Irreversible electroporation, IRE (Procedure)
PRIS 1, arm 2
Men eligible for radical prostatectomy and randomized to the control arm will undergo radical prostatectomy in line with national guidelines.
干预措施: Radical prostatectomy (Procedure)
PRIS 2, arm 2
Men eligible for radiation therapy and randomized to the control arm will undergo radiation therapy in line with national guidelines.
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Primary outcome in PRIS 2: Irritative urinary symptoms
时间窗: 12 months postoperatively
Irritative urinary symptoms defined by Q4e in EPIC-26, Moderate/big problem ("Yes") Versus no/small problem ("No")
Primary outcome in PRIS 1: Urinary continence
时间窗: 12 months postoperatively
Urinary incontinence defined by Q3 in EPIC-26, ≥1 pad/day ("Yes") versus none ("No")
次要结局
- Bowel function(12 months postoperatively)
- Erectile dyfunction(12 months postoperatively)
- Quality of life, EuroQoL-5 Dimensions(12 months postoperatively)
- Treatment Failure, control arm (surgery)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Treatment Failure, experimental arms(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Treatment Failure, control arm (radiation)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Voiding function(12 months postoperatively)
- Adverse events(3 months postoperatively)
研究者
Anna Lantz
MD PhD Principal Investigator Associate Professor
Karolinska Institutet