Carbon-11 Acetate and Fluorine F 18 Sodium Fluoride PET as a Biomarker of Treatment Response in Patients With Hormone Resistant Metastatic Prostate Cancer
PET Imaging as a Biomarker of Systemic Treatment Response for Men With Metastatic Castration-Resistant Prostate Cancer
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. Demonstrate that carbon-11 acetate (11C-acetate) and 18F-fluoride (fluorine F 18 sodium fluoride) PET scans change as a result of treatment for men with metastatic castration-resistant prostate cancer by comparison of pre-treatment and 6-12 week post-treatment images (standardized uptake value [SUV], influx constant [Ki], and rate constant [K1]) with clinical response measures.
SECONDARY OBJECTIVES:
I. Compare results from 11C-acetate and 18F-fluoride PET scanning with the patient's clinical bone scan and determine which predicts clinical response better.
II. Compare changes in 11C-acetate and 18F-fluoride PET with changes in prostate-specific antigen (PSA) level.
III. Compare changes in 11C-acetate and 18F-fluoride PET with changes in urinary N-telopeptide and bone alkaline phosphatase.
IV. Determine if either baseline uptake or change in uptake for 11C-acetate and/or 18F-fluoride PET is correlated with progression-free survival by Prostate Cancer Working Group 2 (PCWG2) criteria (Scher, 2008).
V. Determine if either baseline uptake or change in uptake by 11C-acetate and/or 18F-fluoride PET is correlated with skeletal-related events (SREs) defined as radiographic pathologic fracture, need for radiation to bone, need for surgery, spinal cord compression or malignant hypercalcemia.
VI. Percentage of patients that experience adverse events by Common Terminology Criteria for Adverse Events, version 4.0.
VII. For patients who have tissue/blood biomarkers obtained for other indications, directly compare baseline uptake and change in uptake by 11C-acetate and/or 18F-fluoride PET with those biomarkers.
OUTLINE:
Patients receive carbon-11 acetate intravenously (IV) and fluorine F 18 sodium fluoride IV over 1 minute and undergo PET at baseline and at 6-12 weeks after systemic therapy starts.
After completion of treatment, patients are followed up every 3 months for up to 5 years.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Washington
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Seattle、Washington、アメリカ、98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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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:
- Patients preparing to receive systemic therapy to treat metastatic castration-resistant prostate cancer
- At the time of enrollment, patients must demonstrate evidence of castration-resistant prostate cancer with a documented castrate level of serum total testosterone (< 50 ng/dL) while on continuous androgen deprivation therapy
- Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
- Be willing and able to comply with scheduled visits and other trial procedures
- Presence of at least one measurable or detectable metastasis as defined by bone scintigraphy, computed tomography (CT) scan appearance (magnetic resonance imaging [MRI] if indicated), or plain x-ray appearance
Exclusion Criteria:
- Any condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent
- A serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and imaging studies
- Expected lifespan of 12 weeks or less
- Extremely poor intravenous access, prohibiting the placement of a peripheral IV line for injection of radiotracer
- Radiation treatment to bone less than 4 weeks from the first PET scan
- Radiopharmaceutical treatment to bone less than 4 weeks from first PET scan
- Treatment with granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte (G-CSF) within 4 weeks prior to first PET scan; patients should avoid treatment with these agents between the baseline and 6-12 treatment week imaging sessions
- Inability to lie still for imaging
- Weight > 300 pounds (lbs)
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：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：Diagnostic (11C-acetate, 18F-fluoride, PET)
Patients receive carbon-11 acetate IV and fluorine F 18 sodium fluoride IV over 1 minute and undergo PET at baseline and at 6-12 weeks after systemic therapy starts.
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相関研究
Given IV
Given IV
他の名前：
Undergo 11C-acetate and 18F-fluoride PET
他の名前：
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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 |
|---|---|---|
|
Changes in prostate cancer metastases as measured by 11C-acetate and 18F-fluoride PET in response to systemic therapy
時間枠：Baseline to up to 12 weeks
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Percentage change between pre-treatment and post-therapy measurements will be computed for PET measures.
Log transformations will be considered if the rates of change are highly skewed.
Additionally, changes in PET measures will be analyzed descriptively by a stem-and-leaf plot.
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Baseline to up to 12 weeks
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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 |
|---|---|---|
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Clinical response data (response, stable disease or progression)
時間枠：Up to 5 years
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Molecular imaging measures and clinical measures of treatment response, percentage change in PET derived imaging data will be compared to standard clinical parameters.
Association between these two types of data decline will be analyzed using the mid-P adjustment to Fisher's exact test (Lancaster, 1961) to evaluate the potential clinical utility of change in 11C-acetate and 18F-fluoride as a biomarker for response.
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Up to 5 years
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Proportion of both 11C-acetate and 18F-fluoride PET scans and 99mTc bone scans in discovering suspicious sites that are later confirmed by standard bone scans
時間枠：Up to 5 years
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Statistical significance of two proportions will be tested with a two-sample t-test for proportions (or nonparametric alternative).
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Up to 5 years
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Change in PSA parameters
時間枠：Baseline to up to 30 days post-PET
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Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in PSA.
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Baseline to up to 30 days post-PET
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Change in urinary N-telopeptide
時間枠：Baseline to up to 30 days post-PET
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Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in urinary N-telopeptide.
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Baseline to up to 30 days post-PET
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Change in bone alkaline phosphatase
時間枠：Baseline to up to 30 days post-PET
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Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in bone alkaline phosphatase.
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Baseline to up to 30 days post-PET
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Progression-free survival (PFS) using PCWG2
時間枠：Up to 5 years
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Cox proportional hazards model will be used to investigate the predictive value of the differences in pre- and post- treatment measures on PCWG2 PFS.
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Up to 5 years
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SRE defined as radiographic pathologic fracture, need for radiation to bone, need for surgery, spinal cord compression or malignant hypercalcemia
時間枠：Up to 5 years
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Cox proportional hazards model will be used to investigate the predictive value of the differences in pre- and post- treatment measures on time of first SRE.
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Up to 5 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Evan Yu、Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
- 8021 (その他の識別子：Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
- P30CA015704 (米国 NIH グラント/契約)
- NCI-2014-01203 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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