Neoadjuvant Intraprostatic OnabotulinumtoxinA Before Radical Prostatectomy for High-Risk Localized Prostate Cancer
A Pilot Randomized, Single Blind, Placebo Controlled Study of Neoadjuvant Intraprostatic OnabotulinumtoxinA Prior to Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
研究概览
详细说明
High-risk localized prostate cancer is associated with a substantial risk of adverse pathological features and disease recurrence despite definitive treatment with radical prostatectomy. Emerging evidence suggests that neural signaling within the prostate tumor microenvironment contributes to tumor growth, progression, and treatment resistance. OnabotulinumtoxinA (BOTOX®), a neurotoxin that blocks acetylcholine release, has demonstrated biological effects in prostate tissue and may provide a novel approach to modulating tumor-associated neural pathways.
This single-center, prospective, randomized, single-blind, placebo-controlled pilot study will enroll 30 men with high-risk or very-high-risk localized prostate adenocarcinoma who are scheduled to undergo radical prostatectomy. Participants will be randomized in a 1:1 ratio to receive either a single transrectal ultrasound-guided intraprostatic injection of onabotulinumtoxinA (50 units) or an equivalent-volume normal saline placebo 6 to 8 weeks prior to surgery. Participants will remain blinded to treatment assignment.
The primary objective is to evaluate study feasibility and safety, including participant accrual, protocol adherence, successful completion of intraprostatic injection and planned surgery, and the incidence and severity of adverse events. Secondary objectives include evaluation of pathological outcomes at prostatectomy, including Gleason score, perineural invasion, stromogenic component, tumor burden, pathological stage, and surgical margin status. Early postoperative PSA outcomes will also be assessed. Exploratory analyses will evaluate time to biochemical recurrence following radical prostatectomy.
This pilot study is not powered to demonstrate clinical efficacy. Instead, it is designed to establish the safety and feasibility of neoadjuvant intraprostatic onabotulinumtoxinA and generate preliminary biological and pathological data to support future studies investigating neural modulation as a therapeutic strategy in prostate cancer.
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Vivian MacDonnell, MD
- 电话号码：7134928703
- 邮箱：vmmacdonnell@houstonmethodist.org
研究联系人备份
- 姓名：Brian Miles, MD
- 电话号码：7138170870
- 邮箱：bjmiles@houstonmethodist.org
学习地点
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Texas
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Houston、Texas、美国、77030
- Houston Methodist
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Male, ≥ 45 years
- Histologically confirmed prostate adenocarcinoma
- Gleason score ≥8 on biopsy
- Candidate for and scheduled to undergo RALP for primary treatment
- ECOG 0-2
- Able to read, speak, and understand English
- Able to provide informed consent
Exclusion Criteria:
- Prior prostate cancer therapy (radiation, ADT, chemotherapy)
- Metastatic disease
- Known hypersensitivity to botulinum toxin
- Neuromuscular disorders (e.g., myasthenia gravis)
- Active infection, coagulopathy, or contraindication to transperineal injection
- Medications significantly affecting neuromuscular transmission (clinically relevant)
- Any condition compromising safety or protocol compliance
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Botox
A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy.
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A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy.
其他名称：
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安慰剂比较：Placebo
A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline placebo administered in an identical volume and injection pattern 6 to 8 weeks prior to radical prostatectomy.
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Participants randomized to the placebo arm will receive a single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline administered in an identical volume and injection pattern as the active treatment arm, 6 to 8 weeks prior to planned radical prostatectomy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Participant Accrural
大体时间：Through study completion, an average of 1 year
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Number of participants enrolled in the study
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Through study completion, an average of 1 year
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Protocol Adherence
大体时间：Through study completion, an average of 1 year
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Proportion of participants who complete study procedures according to protocol requirements.
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Through study completion, an average of 1 year
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Successful Completion of Intraprostatic Injection
大体时间：At time of surgery
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Number of participants who successfully receive the assigned intraprostatic study injection.
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At time of surgery
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Incidence of Adverse Events
大体时间：From study injection through 36 months of follow-up.
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Incidence, severity, seriousness, and relationship of adverse events associated with intraprostatic administration of onabotulinumtoxinA or placebo.
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From study injection through 36 months of follow-up.
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Successful Completion of Planned Radical Prostatectomy
大体时间：Within 6 to 8 weeks after intraprostatic injection.
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Proportion of participants who undergo planned radical prostatectomy following study intervention without study-related cancellation or unacceptable delay.
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Within 6 to 8 weeks after intraprostatic injection.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Gleason Score at Radical Prostatectomy
大体时间：At radical prostatectomy (6 to 8 weeks after study injection).
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Comparison of Gleason score determined from radical prostatectomy specimens between treatment arms. Gleason Score determined from radical prostatectomy specimens. Gleason Scores range from 6 to 10, with higher scores indicating more aggressive prostate cancer. |
At radical prostatectomy (6 to 8 weeks after study injection).
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Perineural Invasion
大体时间：At radical prostatectomy (6 to 8 weeks after study injection).
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Presence and extent of perineural invasion identified in radical prostatectomy specimens.
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At radical prostatectomy (6 to 8 weeks after study injection).
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Stromogenic Component
大体时间：At radical prostatectomy (6 to 8 weeks after study injection).
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Assessment of stromogenic component in radical prostatectomy specimens.
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At radical prostatectomy (6 to 8 weeks after study injection).
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Tumor Size
大体时间：At radical prostatectomy (6 to 8 weeks after study injection).
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Tumor size measured in radical prostatectomy specimens.
The measurement will be recorded in centimeters (cm).
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At radical prostatectomy (6 to 8 weeks after study injection).
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Positive Surgical Margin Status
大体时间：At radical prostatectomy (6 to 8 weeks after study injection).
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Proportion of participants with positive surgical margins following radical prostatectomy.
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At radical prostatectomy (6 to 8 weeks after study injection).
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Postoperative Prostate-Specific Antigen (PSA)
大体时间：6 to 8 weeks after radical prostatectomy and during follow-up through 36 months.
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Serum PSA levels following radical prostatectomy.
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6 to 8 weeks after radical prostatectomy and during follow-up through 36 months.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to Biochemical Recurrence
大体时间：Up to 36 months after radical prostatectomy.
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Time from radical prostatectomy to biochemical recurrence as defined by postoperative PSA progression.
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Up to 36 months after radical prostatectomy.
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合作者和调查者
调查人员
- 首席研究员：Brian Miles, MD、Houston Methodist Urology, Houston Methodist Research Institute
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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