前立腺癌の生化学的再発におけるフロセミドの有無による 18F-rhPSMA-7.3 PET/CT の比較
RhPSMA 7.3で膀胱活動を低下させる戦略：前立腺癌の生化学的再発におけるフロセミドの有無による18F-RhPSMA 7.3 PET/CTの比較
This phase II trial evaluates Fluorine-18 radiohybrid prostate-specific membrane antigen (18F- rhPSMA)-7.3 positron emission tomography (PET)/computed tomography (CT) scans with and without furosemide for the reduction of bladder activity in patients with prostate cancer that has come back (recurrent) based on elevated levels of prostate-specific antigen (PSA) in the blood (biochemical) after prostate surgery (prostatectomy). Furosemide is a diuretic substance that increases the urine flow into the bladder, thereby decreasing the level of radioactivity within the bladder, which may help to see any abnormal areas that could be masked by the radioactivity within the bladder. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, rhPSMA ligand. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Adding furosemide to 18F-rhPSMA 7.3 PET/CT scans may help to better detect and treat patients with biochemically recurrent prostate cancer.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVE:
I. To determine if administering 20 mg furosemide intravenously (IV) at the time of radiotracer injection significantly reduces bladder activity compared with the same patient scanned without furosemide as internal control.
SECONDARY OBJECTIVES:
I. To compare detection rates of recurrent disease in blinded interpretations between the furosemide and non-furosemide 18FrhPSMA-7.3 PET/CT scans, with patients serving as their own internal controls.
II. To compare reader confidence in identifying prostate bed and other recurrent lesions on a 18F-rhPSMA-7.3 PET/CT with furosemide compared with 18F-rhPSMA-7.3 PET/CT without furosemide.
OUTLINE:
Patients receive 18F-rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Georgia
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Atlanta、Georgia、アメリカ、30308
- Emory University Hospital Midtown
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Atlanta、Georgia、アメリカ、30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta、Georgia、アメリカ、30342
- Emory Saint Joseph's Hospital
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Johns Creek、Georgia、アメリカ、30097
- Emory Johns Creek Hospital
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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:
- Adenocarcinoma of the prostate, post-prostatectomy
- Biochemical recurrence of prostate cancer following radical prostatectomy (RP) with or without adjuvant or salvage therapy: PSA >= 0.2 ng/mL followed by a subsequent confirmatory PSA value >= 0.2 ng/mL
- Age over 18
- Ability to provide written informed consent
- Patients with standard of care creatinine =< 1.3 mg/dL performed within 90 days prior to enrollment
Exclusion Criteria:
- Inability to undergo 18F-rhPSMA PET-CT, contraindications to furosemide or urinary incontinence
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：診断
- 割り当て：なし
- 介入モデル：順次割り当て
- 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 |
|---|---|
|
実験的：Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT)
Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. |
Undergo PET/CT scan
他の名前：
Undergo PET/CT scan
他の名前：
Given IV
他の名前：
Given IV
他の名前：
|
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 Bladder Activity as Measured by Bladder Standardized Uptake Value (SUV) Mean
時間枠：Up to 2 weeks
|
Change in bladder SUV mean will be assessed using a paired t-test, or using a non-parametric equivalent such as a Wilcoxon signed rank test. Descriptively, change in bladder SUV mean will be reported for those administered 20 mg furosemide intravenously (IV) at the time of radiotracer injection first (group A), and those administered 20mg furosemide IV at the time of radiotracer injection second (group B). |
Up to 2 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Bladder and Renal Activity (Kidney SUV)
時間枠：Up to 2 weeks
|
Kidney SUV - Change in bladder and renal activity will be assessed using paired t-tests, or using non-parametric equivalents such as a Wilcoxon signed rank tests. Descriptively, bladder and renal activity will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B). |
Up to 2 weeks
|
|
Change in Bladder and Renal Activity (Bladder Volume, ML)
時間枠：Up to 2 weeks
|
(Bladder Volume, ML) - Change in bladder and renal activity will be assessed using paired t-tests, or using non-parametric equivalents such as a Wilcoxon signed rank tests. Descriptively, bladder and renal activity will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B). |
Up to 2 weeks
|
|
Recurrent Disease Rate
時間枠：Up to 2 weeks
|
Defined as presence of unequivocal soft tissue radiotracer uptake that is characteristic of malignancy in the prostate bed and/or surrounding soft tissues and within pelvic lymph nodes. Recurrent disease rates will be compared (furosemide versus non-furosemide flotufolastat F-18 radiohybrid prostate-specific membrane antigen (18F-rhPSMA)-7.3 positron emission tomography (PET) scans using McNemar's tests. Rates will be reported, along with 95% exact confidence intervals using the Clopper-Pearson method. Descriptively, recurrent disease rate will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B). |
Up to 2 weeks
|
|
Reader Confidence Score
時間枠：1 Month
|
The readers' confidence in identifying prostate bed, pelvic and retroperitoneal nodal disease and other recurrence on 18F-rhPSMA-7.3 PET/computed tomography (CT) with furosemide compared with the 18F-rhPSMA-7.3 PET/CT without furosemide will be scored using a 5-point Likert scale ( 1 - Definitely benign, 2- probably benign, 3 - equivocal, 4 - probably malignant, 5 - definitely malignant). This analysis will be descriptive, with summary statistics reported with and without furosemide. Variables will be summarized using frequencies and percentages. In our analysis, 1,2 (no) will be considered benign while 3,4,5 malignant (yes). A high Likert score indicates that the reader is confident that the finding on the imaging is cancer (worse outcome), while a low score indicates no cancer (better outcome). All tests will be two-sided with an alpha level of 0.05, unless otherwise noted. Statistical analysis will be conducted using SAS 9.4. |
1 Month
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Charles V. Marcus, MBBS、Emory University Hospital/Winship Cancer Institute
出版物と役立つリンク
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 (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
- STUDY00004720
- P30CA138292 (米国 NIH グラント/契約)
- STUDY00004720 (その他の識別子：Emory University Hospital/Winship Cancer Institute)
- RAD5689-22-BED-IIT-439 (その他の識別子：Emory University Hospital/Winship Cancer Institute)
- NCI-2023-01322 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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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