Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Feasibility as measured by percentage of subjects assessed at 12 weeks post-IRE
研究概览
简要总结
This is a single-site trial for 42 subjects with intermediate risk prostate cancer who undergo Irreversible Electroporation (IRE) followed by Magnetic Resonance guided Radiotherapy MRgRT. The investigators hypothesize that the combined therapy will feasible and be safe to perform with low morbidity. Ultimately, RTIRE may provide optimal treatment for intermediate risk prostate cancer patients.
详细描述
The primary objective is to determine feasibility of combining IRE and SBRT. Feasibility is defined at 80% of subjects assessed at 12 weeks post-IRE/6 weeks post-MRgRT within 1 year from first subject enrollment.
Rationale
- Focal therapy with IRE offers a low side effect profile of treatment but risk of recurrence
- Lower dose MRgRT offers the potential benefit of limiting radiation dose received by normal tissues, namely the bladder and rectum, with advanced MR image guidance, real- time volume adaptability and dose delivery techniques.
- Combined IRE and MRgRT may provide optimal treatment of prostate cancer while minimizing side effects
Patients with intermediate risk prostate cancer are at higher risk of progressing while on active surveillance when compared to men with low-risk prostate cancer. The benefits of definitive treatment with RT or surgery may not outweigh the risks of surveillance in intermediate risk prostate cancer patients due to increased morbidity of treatment. Focal therapy with IRE is effective in treating prostate cancer with minimal side effects but has a high risk of recurrence, especially in patients with nontreated low risk prostate cancer. Lower dose RT may treat low risk prostate cancer and reduce the risk of recurrence after treatment. RTIRE may be a treatment option for some patients with intermediate risk prostate cancer.
Study Completion A participant is considered to have completed the study if he has completed all phases of the study including the last visit or the last scheduled procedure. The end of the study is defined as completion of the last visit or procedure shown in the SoA in the trial globally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged ≥ 18
- •Histologically confirmed intermediate risk prostate cancer per NCCN guidelines.
- •Focal grade group 2 or 3 (GS 3+4 or GS 4 + 3) cancer in MRI target
- •Gland size < 80 cc
- •Ability to undergo IRE
- •Ability to receive MRI-guided radiotherapy.
- •Ability to complete the HRQOL assessment surveys
- •Willingness to undergo 12 month follow up biopsy
排除标准
- •Prior history of focal therapy.
- •Prior history of receiving pelvic radiotherapy.
- •Patient with metastatic prostate cancer.
- •Patient with history of inflammatory bowel disease.
- •Inability to undergo general anesthesia
- •Inability to be placed within the lithotomy position for a transperineal approach to both biopsy and treatment.
- •Patients with a prior or concurrent disease whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the Principal Investigator.
- •History of bladder neck or urethral stricture.
研究组 & 干预措施
Irreversible Electroporation and Radiotherapy
干预措施: IRE & MRgRT (Device)
结局指标
主要结局
Feasibility as measured by percentage of subjects assessed at 12 weeks post-IRE
时间窗: 12 weeks
Feasibility is defined at 80% of subjects (8 subjects) assessed at 12-week post-IRE
Feasibility as measured by percentage of subjects assessed at 6 weeks post-MRgRT within 1 year
时间窗: 6 weeks
Feasibility is defined as 80% of subjects (8 subjects) assessed at 6 weeks post-MRgRT within 1 year
Proportion of patients who remain cancer-free
时间窗: 12 months
Phase II primary objective: determine the potential efficacy of combined IRE and SBRT at the 1-year follow-up.
次要结局
- Number of treatment-related adverse events(up to 12 months)
- Change in Impact of RTIRE on health-related quality of life as measured by the International Prostate Symptom Score (IPSS)(Baseline, Every 3 months (up to 60 Months))
- Prostate multiparametric MRI changes(Baseline, immediately post IRE procedure,3 month post procedure, and 12 months post procedure)
- Change in Impact of RTIRE on health-related quality of life as measured by International Index of Erectile Function (IIEF-5)(Baseline, Every 3 months (up to 60 Months))
- Oncologic efficacy of RTIRE as measure by the number of subjects with presence of clinically significant (Greater than grade group1) prostate cancer(12 months)
- change in Impact of RTIRE on health-related quality of life as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)(Baseline, Every 3 months (up to 60 Months))
- Prostate Specific Antigen(Baseline, Every 3 months (up to 60 Months))