Enzalutamide in Patients With High-risk Prostate Cancer
A Phase 2 Study of Enzalutamide in Patients With High-risk Prostate Cancer Who Have Undergone Local Definitive Therapy With Radical Prostatectomy
The purpose of this study is to see how long it takes for prostate cancer to come back in patients who have had surgery to remove their prostate gland (radical prostatectomy), while being treated with enzalutamide (formerly known as MDV3100).
Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks activity of the male hormone, testosterone. Most prostate cancers are dependent on testosterone for growth. In this study, patients will take enzalutamide after surgery to see if it keeps their cancer from coming back.
調査の概要
詳細な説明
This is a pilot phase II study evaluating the clinical activity and safety of Enzalutamide (formerly known as MDV3100) a novel androgen receptor (AR) inhibitor in men with high-risk prostate cancer who have undergone local definitive therapy with radical prostatectomy.
Primary Objectives:
-To evaluate the clinical efficacy of enzalutamide in patients with high-risk prostate cancer with regards to: Time to disease progression defined by biochemical recurrence (BCR)
Secondary Objectives:
-To further evaluate the safety of enzalutamide in patients with high-risk prostate cancer
Patients will receive daily oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD). Patients will continue on study until progressive disease, drug intolerability, consent withdrawal or completion of study at 24 months.
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
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
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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:
- Understand and voluntarily sign an informed consent form.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed adenocarcinoma of the prostate.
Patients must have undergone a Radical Prostatectomy (any surgical technique is permitted) within 3 months from study entry and have high-risk disease define by any of the following:
- Pathological stage T3a, T3b, T4 (any grade or iPSA)
- Gleason' sum ≥ 8 (any stage or iPSA)
- Initial Pre-operative PSA ≥ 20ng/mL (any GS or pT stage)
- Any stage/PSA/Gleason patients with a 35% or greater chance of biochemical failure at 5 years based on Kattan's nomogram http://nomograms.mskcc.org/Prostate/PostRadicalProstatectomy.
- Patients with Lymph node (LN) positive disease, regardless of iPSA, pT stage or GS provided their post-operative PSA 6-8 weeks after surgery is ≤ 0.4ng/mL. (Lymph node dissection is desired but not mandated)
- Able to swallow the study drug and comply with study requirements.
Patients must have normal organ and marrow function as defined below:
- Testosterone ≥ 50 ng/dL per laboratory reference range
- Baseline Post-RP PSA ≤ 0.4
- Hemoglobin ≥ 10.0 g/dL independent of transfusion
- Absolute neutrophil count ≥1,500/mcL
- Platelet count ≥100,000/ìL
- Serum albumin ≥ 3.5 g/dL
- Serum potassium ≥ 3.5 mmol/L
- Liver function: serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert's disease) and AST or ALT < 2.5 x ULN
Exclusion Criteria:
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment
- Prior radiotherapy to the prostate or pelvis (related to prostate cancer). Concurrent adjuvant radiation therapy is permitted once patient has been enrolled on trial.
- Prior use of Abiraterone acetate or cytotoxic chemotherapy for prostate cancer
- Prior androgen deprivation with Luteinizing hormone-releasing hormone (LHRH) is permitted provided that testosterone levels prior to study entry have recovered to normal limits per reference laboratory.
- No prior anti-androgen therapy (bicalutamide, flutamide or Nilutamide) is permitted
- Prior use of 5-alpha reductase inhibitors is permitted provided such medications were stopped 7-14 days prior to enrollment
- Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 2 weeks of enrollment
- Active unresolved infection
- Known history of central nervous system (CNS) metastases
- Patients must have no known history of HIV
- Evidence of metastatic disease as evidenced by a CT or MRI of abdomen and pelvis and/or whole body bone scan (WBS). To be done prior to treatment start and up to 4 months prior to radical prostatectomy date.
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of enrollment.
Clinically significant cardiovascular disease including:
- Myocardial infarction within 6 months prior to Screening;
- Uncontrolled angina within 3 months prior to Screening;
- Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%
- History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
- Hypotension as indicated by systolic blood pressure < 86 mmHg at the Screening visit
- Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG
- Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening visit
- Gastrointestinal disorder affecting absorption (e.g., Gastrectomy, active peptic ulcer disease within last 3 months)
- Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.
- The effects of enzalutamide on the developing human fetus at the recommended therapeutic doses are unknown. Thus, men must agree to use adequate contraception (barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for 6 months after the usage of enzalutamide. Should the patient's partner become pregnant or suspect she is pregnant while the patient is participating in this study, the patient should inform his treating physician immediately.
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: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 |
---|---|
実験的:Enzalutamide
Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
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oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
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 |
---|---|---|
To Evaluate the Clinical Efficacy of Enzalutamide
時間枠:2 years
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Clinical efficacy is measured as time to disease progression defined by biochemical recurrence (BCR).
BCR was defined as PSA ≥0.2ng/mL on 2 consecutive lab results or any PSA rise that resulted in subsequent therapy.
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2 years
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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 |
---|---|---|
Safety of Enzalutamide
時間枠:2 years
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The number of patients that experience adverse events related to the study drug.
NCI Cancer Clinical Trials Common Toxicity Criteria (version 4.0) will be utilized.
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2 years
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Impact of Enzalutamide on Circulating Tumor Cells (CTCs)
時間枠:2 years
|
Quantify mRNA levels of Survivin in CTCs obtained from patients pre- and post-treatment with enzalutamide using the Veridex Cell Search Profile kit.
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2 years
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協力者と研究者
捜査官
- 主任研究者:Jorge Garcia, MD、Case Comprehensive Cancer Center
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 (実際)
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 (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
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。
enzalutamideの臨床試験
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Astellas Pharma Europe B.V.Medivation, Inc.完了前立腺がん | デキストロメトルファンの薬物動態 | カフェインの薬物動態モルドバ共和国