前立腺温存膀胱切除術の安全性と有効性の評価
膀胱がん患者における前立腺カプセル温存と神経温存の根治的膀胱切除術を比較する前向きランダム化試験
The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy. Patients will be randomized to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy. Patients will be monitored following standard of care guidelines and clinical data will be collected. Patients in both groups will be asked to complete an erectile function questionnaire at multiple timepoints. Patients who receive an orthotopic neobladder will be asked to complete a questionnaire to monitor urinary function at multiple timepoints. Patient adverse events will be monitored to ensure patients safety.
調査の概要
状態
条件
詳細な説明
The purpose of this study is to determine if prostate capsule-sparing cystectomy improves functional outcomes without compromising the oncologic outcomes in patients with bladder cancer. The comparison arm will be patients undergoing nerve-sparing radical cystectomy. Participants will be randomized to receive either a nerve-sparing radical cystectomy or a prostate capsule-sparing radical cystectomy. Patients will be monitored following standard of care guidelines every 3-months post-operatively up to and including 24 months post-operatively. As part of standard of care post-operative follow-up patients will have routine history and physical exams, urine cytology, urine culture, Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), and Prostate Specific Antigen (PSA). Standard of Care diagnostic imaging will also occur. The Sexual Health Inventory for Men (SHIM) Questionnaire will be given to patients 6-weeks post-operatively and every 3-months post-operatively up to and including 24-months post-operatively. To measure urinary function in patients who receive orthotopic neobladder, the Validated Pad Questionnaire will be given 6-weeks post-operatively and every 3-months post-operatively up to and including 24-months post operatively. Adverse Events will be monitored in both groups as defined by the CTCAE 5.0 guidelines.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Armine Smith, MD
- 電話番号：202-660-5561
- メール：asmit165@jhmi.edu
研究連絡先のバックアップ
- 名前：Domani Rodriguez
- メール：drodri59@jh.edu
研究場所
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20016
- 募集
- Sibley Memorial Hospital
-
コンタクト：
- Armine Smith, MD
- 電話番号：202-660-5561
- メール：asmit165@jhmi.edu
-
コンタクト：
- Domani Rodriguez
- メール：drodri59@jh.edu
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21287
- 募集
- Johns Hopkins Hospital
-
コンタクト：
- Armine Smith, MD
- 電話番号：202-660-5561
- メール：asmit165@jhmi.edu
-
コンタクト：
- Domani Rodriguez
- メール：drodri59@jh.edu
-
-
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:
- Subjects with pathologically confirmed bladder cancer scheduled for radical cystectomy
- Variant histologies of bladder cancer permitted
- Neoadjuvant therapy permitted
- Age > 18 years old
- Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
- Patients that are not candidates for cystectomy
- Moderate to severe erectile dysfunction with SHIM score <17
- Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra
- Prior pelvic radiation
- Confirmed prostate cancer:
- Patients with abnormal Digital rectal exam (DRE), PSA >3 or Prostate Imaging Reporting & Data System (PIRADS) 4 lesions on prostate Multiparametric MRI (mpMRI) will undergo prostate biopsy to rule out prostate cancer
- Increased genetic risk of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines:
- ≥1 first-, second-, or third-degree relative with: breast cancer at age ≤50 y, colorectal or endometrial cancer at age ≤50 y, male breast cancer at any age, ovarian cancer at any age, exocrine pancreatic cancer at any age, metastatic, regional, very-high-risk, high-risk prostate cancer at any age
- ≥1 first-degree relative (father or brother) with: prostate cancer at age ≤60 y
- ≥2 first-, second-, or third-degree relatives with: breast cancer at any age, prostate cancer at any age
- ≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed
- Patients with Lynch syndrome
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：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 |
|---|---|
|
他の：Prostate Capsule-Sparing Radical Cystectomy
Patients randomized to this arm will receive the prostate capsule-sparing surgery performed in the form of standard simple prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder. |
Patients randomized to this arm will receive the prostate capsule-sparing surgery performed in the form of standard simple prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder. |
|
他の：Nerve-Sparing Radical Cystectomy
Patients randomized to this arm will receive the nerve-sparing surgery will be performed in the form of the standard nerve-sparing radical prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder. |
Patients randomized to this arm will receive the nerve-sparing surgery will be performed in the form of the standard nerve-sparing radical prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder. |
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 |
|---|---|---|
|
Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM)
時間枠：Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively, 24-months post-op
|
Comparison of functional outcomes focusing on preservation of erectile function in patients undergoing cystectomy for bladder cancer. Functional Outcomes will be measured by the Sexual Health Inventory for Men (SHIM) Questionnaire. The Sexual Health Inventory for Men defines the following ranges of Erectile Dysfunction (ED): 1-7 is Severe ED, 8-11 Moderate ED, 12-16 Mild to Moderate ED, and 17 to 21 is Mild ED. |
Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively, 24-months post-op
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in urinary function in patients with orthotopic neobladder as assessed by the Validated Pad Questionnaire
時間枠：Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively , 24-months post-op
|
Urinary function in patient with orthotopic neobladder urinary diversions measured using the Validated Pad Questionnaire. The Validated Pad questionnaire will be used to determine the percentage of patients utilizing 1 to 2 pads versus 2 or more pads for night and day, respectively. |
Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively , 24-months post-op
|
|
Change in overall patient survival
時間枠：Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively, 24-months post-op
|
Comparing the overall survival of patients in both arms of the study |
Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively, 24-months post-op
|
|
Change in disease specific status
時間枠：Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively, 24-months post-op
|
Comparing the status of disease specific in both arms of the study |
Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively, 24-months post-op
|
|
Soft tissue surgical margin rate as assessed by pathology
時間枠：Up to 4-weeks after surgical intervention
|
Pathologists will examine the soft tissue surgical margin rate to determine positive or negative soft tissue surgical margin. |
Up to 4-weeks after surgical intervention
|
|
Safety as assessed by adverse events experienced by study participants
時間枠：Up to 24-months post-operative
|
Comparing the differences in adverse events (grades 2-5) as experienced by the participants of in each study arm. The grading of adverse events are defined by the CTCAE 5.0 guidelines. |
Up to 24-months post-operative
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Armine Smith, MD、Johns Hopkins University
研究記録日
主要日程の研究
研究開始 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00345549
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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