A Pilot Randomized, Single Blind, Placebo Controlled Study of Neoadjuvant Intraprostatic OnabotulinumtoxinA Prior to Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Participant Accrural
研究概览
简要总结
This pilot randomized, single-blind, placebo-controlled study evaluates the feasibility, safety, and preliminary biological activity of neoadjuvant intraprostatic onabotulinumtoxinA (BOTOX®) administered before radical prostatectomy in men with high-risk localized prostate cancer. Thirty participants will be randomized 1:1 to receive a single transrectal ultrasound-guided intraprostatic injection of onabotulinumtoxinA (50 units) or placebo 6 to 8 weeks before surgery. Outcomes include feasibility metrics, safety, adverse events, pathological findings at prostatectomy, and postoperative prostate-specific antigen (PSA) levels
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant will not know if they are receiving Botox or placebo, they will remain blinded.
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, ≥ 45 years
- •Histologically confirmed prostate adenocarcinoma
- •Gleason score ≥8 on biopsy
- •Candidate for and scheduled to undergo RALP for primary treatment
- •Able to read, speak, and understand English
- •Able to provide informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: OnabotulinumtoxinA (BOTOX®) (Drug)
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.
干预措施: Normal Saline Placebo (Other)
结局指标
主要结局
Participant Accrural
时间窗: Through study completion, an average of 1 year
Number of participants enrolled in the study
Protocol Adherence
时间窗: Through study completion, an average of 1 year
Proportion of participants who complete study procedures according to protocol requirements.
Successful Completion of Intraprostatic Injection
时间窗: At time of surgery
Number of participants who successfully receive the assigned intraprostatic study injection.
Incidence of Adverse Events
时间窗: From study injection through 36 months of follow-up.
Incidence, severity, seriousness, and relationship of adverse events associated with intraprostatic administration of onabotulinumtoxinA or placebo.
Successful Completion of Planned Radical Prostatectomy
时间窗: Within 6 to 8 weeks after intraprostatic injection.
Proportion of participants who undergo planned radical prostatectomy following study intervention without study-related cancellation or unacceptable delay.
次要结局
- Gleason Score at Radical Prostatectomy(At radical prostatectomy (6 to 8 weeks after study injection).)
- Perineural Invasion(At radical prostatectomy (6 to 8 weeks after study injection).)
- Stromogenic Component(At radical prostatectomy (6 to 8 weeks after study injection).)
- Tumor Size(At radical prostatectomy (6 to 8 weeks after study injection).)
- Positive Surgical Margin Status(At radical prostatectomy (6 to 8 weeks after study injection).)
- Postoperative Prostate-Specific Antigen (PSA)(6 to 8 weeks after radical prostatectomy and during follow-up through 36 months.)
研究者
Brian Miles
Principal Investigator
The Methodist Hospital Research Institute