Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer
A Study of Changes in the Prostate Following Androgen Deprivation to Investigate Therapy Response and Resistance in Clinical Prostate Cancer
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at blood and tissue samples from patients with prostate cancer receiving androgen deprivation therapy.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
- To identify the molecular and pathophysiological changes which occur during the early stages of androgen deprivation (AD) and during emerging castration-resistant prostate cancer.
- To test functional imaging as a non-invasive tool to measure treatment response and validate this using biological endpoints.
- To develop clinical models to predict how tumors will respond to AD and identify new targets once AD fails.
OUTLINE:
- Group A: Patients likely to receive androgen deprivation (AD) as first-line therapy undergo blood and prostate biopsy sample collection before and after treatment on days 0 and 14 or 90. Patients receive an androgen receptor inhibitor followed by maintenance with a gonadotropin-releasing hormone analogue beginning on day 0. Patients also undergo diffusion-weighted MRI, MR spectroscopic imagining, quantitative T1W mapping, and T1W perfusion sequence.
- Group B: Patients already receiving AD undergo blood and prostate biopsy sample collection within 4 weeks of diagnosis of castration-resistant prostate cancer and before initiating any second-line therapy.
Blood and tissue samples are assessed via DNA and RNA genetic analysis, gene expression studies, and comparative genomic hybridization to identify novel markers of androgen response and resistance.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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England
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Cambridge、England、イギリス、CB2 0RE
- 募集
- Cancer Research UK at Cambridge Research Institute
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コンタクト:
- Vincent Gnanapragasam, MD
- 電話番号:44-1223-348-363
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参加基準
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
受講資格のある性別
説明
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
- High clinical suspicion of prostate cancer, based on an abnormal digital rectal examination and PSA (> 20 ng/mL)
Newly diagnosed, castration-resistant prostate cancer
- Clinical stage ≥ T2c disease
- Significant tumor volume on initial diagnostic biopsy (> 50% of cores)
- Likely to receive androgen deprivation therapy for prostate cancer
PATIENT CHARACTERISTICS:
- No contraindication to transrectal needle biopsy
- No contraindication to MRI or prostate needle biopsy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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:非ランダム化
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 |
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Identification of molecular and pathophysiological changes
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Functional imaging as a non-invasive tool to measure treatment response
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Development of clinical models to predict tumor response
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Vincent Gnanapragasam, MD、Cancer Research UK
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
- CDR0000639017
- CRUK-CHIRRP
- EU-20920
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。