A Phase I Open Label Peri-prostatic Neuraxial Block With Lidocaine and Ethanol in High-risk Localized Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Dose-Limiting Toxicity (DLT)
研究概览
简要总结
Disease progression after definitive therapy for prostate cancer is a major source of morbidity and mortality. Adrenergic/sympathetic innervation of the prostate is essential for prostate cancer progression, and abrogation of these signals by blocking adrenergic innervation halts disease progression. Long-acting neuraxial block of the sympathetic nerves that innervate the pelvis with dehydrated alcohol (>98% Ethanol) is a safe and effective tool in the treatment of chronic pelvic pain and cancer- induced pelvic pain. Furthermore, ultrasound guided periprostatic neuraxial block at the time of prostate biopsy with short-acting lidocaine is standard of care. Herein the research team proposes to administer a long-acting periprostatic neuraxial block with dehydrated alcohol and lidocaine under trans rectal ultrasound guidance in patients with high-risk clinical features for prostate cancer at the time of prostate biopsy.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •PSAD >0.15
- •PI-RADS 5 lesion on MRI
- •Karnofsky performance status >80
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Prior or concomitant treatment for prostate cancer, including radiation therapy, focal therapy, cryo therapy, androgen deprivation therapy.
- •Imaging or clinical evidence of metastatic disease.
- •PSA > 100ng/mL
研究组 & 干预措施
Long-acting neuraxial blockade
Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol + lidocaine.
干预措施: Dehydrated alcohol (Drug)
Long-acting neuraxial blockade
Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol + lidocaine.
干预措施: Lidocaine IV (Drug)
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: At week 2
The DLT will be measured in the two week post administration period. The target toxicity rate is assumed as 25% considering immediate post-administration toxicity. This rate will not account for the delayed onset toxicities.
Maximally Tolerated Dose (MTD)
时间窗: At week 2
The MTD will be defined as the dose at which the isotonic estimate of the toxicity rate is closest to the target toxicity rate of 25%. The MTD will be used as a recommended dose for prospective Phase II study in future
次要结局
- Time to biochemical recurrence(at month 6 and at year 2)
- Response Rate(at week 8)
- Tumor immunogenicity(at week 8)
- Degree of neural inhibition(at week 8)
研究者
Ali Zahalka
Clinical Instructor
Icahn School of Medicine at Mount Sinai