Effect of Weight Loss on Prostate Cancer Pathology
2018年8月17日 更新者：VA Office of Research and Development
The purpose of this study is to determine if weight loss prior to radical prostatectomy effects chemical substances in the blood stream and prostate tissue that may affect prostate cancer development and progression.
調査の概要
詳細な説明
Obesity is an epidemic, a major public health concern, and is a significant risk factor for progression and mortality from prostate cancer.
Prior work in the investigators' laboratory in pre-clinical prostate cancer models and in obese men found that a low fat diet, exercise, and weight loss resulted in antiproliferative and pro-apoptotic effects on prostate cancer tissue through mechanisms related to the IGF-axis.
The investigators now propose to conduct a prospective, randomized clinical trial in overweight and obese men with prostate cancer undergoing radical prostatectomy to evaluate if weight loss prior to radical prostatectomy results in antiproliferative and pro-apoptotic effects in prostate cancer tissue.
The investigators will accomplish this aim by enrolling overweight and obese men with prostate cancer scheduled to undergo radical prostatectomy.
Following informed consent, men will be randomized to either immediate radical prostatectomy or to an 8-week weight loss intervention group that will undergo a diet and exercise weight loss program followed by radical prostatectomy.
Proliferation and apoptosis of prostate cancer cells in the prostatectomy specimen will be compared between the groups and relative to the baseline prostate needle biopsy specimens.
Further studies will evaluate potential serum surrogate biomarkers that the investigators developed in the investigators' laboratory (ex-vivo serum bioassays) and serum and tissue IGF-axis proteins that have previously been related to obesity, weight loss, and prostate cancer progression.
The goal of the investigators' project will be to evaluate the potential anticancer effects of weight loss on prostate cancer tissue and to identify surrogate serum biomarkers that reflect antiproliferative and pro-apoptotic tissue effects and can be applied to future secondary prevention trials in overweight and obese prostate cancer survivors.
研究の種類
介入
入学 (実際)
44
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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West Los Angeles、California、アメリカ、90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
Inclusion Criteria:
- Subject is overweight or obese (BMI > 25 kg/m2)
- Patient with pathologically confirmed adenocarcinoma of the prostate and has elected to undergo radical prostatectomy
- Willing to delay radical prostatectomy for 5 to 8-weeks if randomized to the weight loss intervention group.
- Able to adhere to physical activity intervention (able to walk for 30 minutes without rest)
- Able to come to the VA for weight loss visits during the 5 to 8-wk study
Exclusion Criteria:
- Any one of the following: Gleason grade > 4+4, PSA > 20.
- History of ever receiving androgen deprivation therapy, antiandrogen therapy, or finasteride
- Prior prostate radiotherapy (external beam or brachytherapy) or prior cryotherapy
- Diagnosis of diabetes mellitus and on insulin**
- Current use of weight loss medications or enrolled in a diet/weight loss program
- Current use of lycopene supplements*** Significant co-morbidities (i.e. cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) Cardiac pacemaker
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：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 |
|---|---|
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実験的：Arm 1: Weight Loss
Weight Loss Group
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Subjects undergo a weight loss intervention prior to radical prostatectomy.
The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
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アクティブコンパレータ：Arm 2: No Weight Loss
No Weight Loss Group
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These subjects do not undergo a weight loss intervention prior to radical prostatectomy.
This group does undergo DEXA scanning, blood draws, and anthropometrics prior to 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 |
|---|---|---|
|
Apoptotic Index of the Highest Gleason Grade Malignant Epithelium in the Radical Prostatectomy Specimen Obtained After 8-weeks of the Dietary Intervention
時間枠：8 weeks
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The primary objective is to compare the mean apoptotic index in the radical prostatectomy malignant epithelium between the Weight Loss Group and the Control Group-No Weight Loss.
The apoptotic index will be measured in the malignant epithelium with the highest Gleason grade.
TUNEL staining was used to identify these apoptotic cells and measure the apoptotic index, which is the percent of cells stained from the sample.
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8 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 |
|---|---|---|
|
Proliferative Index in Prostate Cancer Epithelium Specimen
時間枠：8 weeks
|
The proliferative index in prostate cancer epithelium obtained from the radical prostatectomy specimen.
This index was procured by staining the Ki67 protein to measure cell proliferation.
(Note: Ki67 is a common indicator of cell proliferation.)
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8 weeks
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Change in Serum IGF-related Analytes: IGF-1
時間枠：baseline and post-intervention
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This outcome is the measure of the hormone insulin-like growth factor 1 at baseline vs. post-intervention.
We measured and compared the concentration (ng/mL) of this hormone.
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baseline and post-intervention
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Change in Serum IGF-related Analytes: IGFBP-1
時間枠：baseline and post-intervention
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This outcome is the measure of the protein, insulin-like growth factor binding protein 1, at baseline vs. post-intervention.
We measured and compared the concentration (ng/mL) of this protein.
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baseline and post-intervention
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Ex-vivo Mitogenic and Apoptotic Activity of Patient Sera on LNCaP Cells
時間枠：baseline and post-intervention
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The BRDU assay measures proliferation of cultured cells such as LNCaP.
We expose the cells to the patient blood and see if it inhibits prostate cancer cell growth ex vivo.
We use optical density (a measure of the amount of light able to pass through the specimen) to indicate the concentration of cell proliferation.
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baseline and post-intervention
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Change in Body Weight
時間枠：baseline and post-intervention
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This change in body weight is observed by DEXA, a scanner that measures total body composition.
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baseline and post-intervention
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Change in Percent Body Fat
時間枠：baseline and post-intervention
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This change in percent body fat is observed by DEXA, a scanner that measures total body composition.
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baseline and post-intervention
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：William Aronson, MD、VA Greater Los Angeles Healthcare System, West Los Angeles, CA
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年1月1日
一次修了 (実際)
2016年3月1日
研究の完了 (実際)
2016年3月1日
試験登録日
最初に提出
2007年5月17日
QC基準を満たした最初の提出物
2007年5月18日
最初の投稿 (見積もり)
2007年5月21日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月31日
QC基準を満たした最後の更新が送信されました
2018年8月17日
最終確認日
2018年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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