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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Vivian MacDonnell, MD
- 電話番号：7134928703
- メール：vmmacdonnell@houstonmethodist.org
研究連絡先のバックアップ
- 名前：Brian Miles, MD
- 電話番号：7138170870
- メール：bjmiles@houstonmethodist.org
研究場所
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Texas
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Houston、Texas、アメリカ、77030
- Houston Methodist
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant Accrural
時間枠：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
時間枠：Through study completion, an average of 1 year
|
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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gleason Score at Radical Prostatectomy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to Biochemical Recurrence
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Brian Miles, MD、Houston Methodist Urology, Houston Methodist Research Institute
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Pro00046310
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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