The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal Therapy
The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal therapy-a Phase I Study
調査の概要
詳細な説明
Background:
Prostate cancer is the most common cancer in elderly males in western country. It is also a major health concern, especially in China with its greater proportion of elderly men in the general population. Currently, radical prostatectomy(RP) is the mainstream treatment for localized PCa to show a benefit for cancer-specific survival (CSS). However, the patient who underwent RP might suffer from the complication of erectile dysfunction or urinary incontinence. In 2004, a new method using steep pulses to treat tumor was appeared. It showed that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading tonecrosis of tumor cells. And it seemed to do no harms to the nerve and Vascular epithelial cell. The device of steep pulse had already been approved by FDA in 2011.However, this device of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury; (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite Steep-pulse Treatment Apparatus, may have the potential to conquer these disadvantages.
Purpose:
- This study will assess the efficacy of Composite Steep-pulse Treatment Apparatus in the treatment of PCa.
- This study will assess potency, urinary continence and complication rate for the patients undergo the treatment with steep pulse device.
- Histopathological analysis of prostate speciem 4 weeks after treated by Composite Steep-pulse Treatment Apparatus.
Methods:
- patients recruitment
- transperineal prostate targeted biopsy guided by multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion, plus systemic prostate biopsy.
- Frozen pathological analysis will be performed;
- Irreversible Electroporation of malignant Tumor Cell under Composite Steep-pulse Treatment for the patients with positive biopsy;
- Complication, urinary continence, and sexual function will be evaluated after the IRE treatment;
- RP for these patients in 4 weeks after the treatment of Composite Steep-pulse Treatment.
- Histopathological Outcomes analysis will be performed to evaluate tumor residual rate, urethral injuries, nerve injuries and capsule injury in and beside the ablation area.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Shanghai
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Shanghai、Shanghai、中国、200000
- Changhai Hospital,Second Military Medical University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Prostate MRI can identify the suspect region(pi-RADS≥4 ) ,and no evidence of lymphatic metastasis
- Patients must have confirmed prostate cancer by prostate biopsy
- There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
- No prostatic calculus or prostatic calculus≤5mm
- No contraindication on total intravenous anesthesia
- Not take any anticoagulants before or discontinue anticoagulant therapy at least 7 days
- Age ≥ 30 - ≤ 75 years
- Life expectancy of greater than 10 years
- Patients scheduled for radical prostatectomy.
- Sexually potent
Exclusion Criteria:
- Patients have previously undergone radical prostatectomy.
- Patients have previously undergone hormonal therapy or radiotherapy.
- Patients underwent other surgery before less than 3 months
- Clinically significant cardiovascular disease
- Patients with other malignant tumor or patients with hiv.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with poor health condition
- Simultaneous participation in another clinical trial
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：Steep Pulse Device
Applying the steep pulse to treat the patients with Prostate cancer
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Applying the steep pulse to treat the patients with Prostate cancer
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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 |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure
時間枠：1 Year
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To determine if the IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma.
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1 Year
|
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Efficacy (persentage of unablated tissue un the ablation zone)
時間枠：1 month
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Persentage of normal glandular tissue in the specified targeted ablation zone by histopathology assessment
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1 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sexual function
時間枠：1 month
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Mean sexual function domain score (IIEF-5 scoring: The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction) |
1 month
|
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Urinary incontinence
時間枠：1 month
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Mean urinary incontinence domain score (the number of pad everyday,good is less than 2 pads a day, more or equal than 2 pads a day)
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1 month
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協力者と研究者
捜査官
- 主任研究者：yinghao sun, MD,PHD、Changhai Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
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