Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer
2020年11月16日 更新者：Duke University
A Phase II Open-label, Parallel Group Study of Abiraterone Acetate Plus Prednisone in African American and Caucasian Men With Metastatic Castrate-resistant Prostate Cancer
The primary goal is to prospectively estimate the median radiographic PFS of African American and Caucasian men with mCRPC to abiraterone acetate and prednisone.
調査の概要
詳細な説明
This is a non-comparative pilot open-label, parallel arm, multicenter study of abiraterone acetate in African American and Caucasian men with mCRPC.
Patients will self-report on race and 50 patients will be enrolled into each group.
Patients will be treated on open-label treatment until evidence of disease progression as defined by Prostate Cancer Working Group Two (PCWG2) definition or until two years at which point they will roll over to the standard of care at that time.
The study agent abiraterone acetate will be administered by the patient at a dose of 1000mg orally once daily with prednisone 5 mg BID in 4-week cycles throughout the treatment period.
研究の種類
介入
入学 (実際)
100
段階
- フェーズ2
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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Alabama
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Birmingham、Alabama、アメリカ、35233
- Birmingham VA Medical Center
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Louisiana
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New Orleans、Louisiana、アメリカ、70112
- Tulane Cancer Center
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Michigan
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Detroit、Michigan、アメリカ、48201
- Karmanos Cancer Institute
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke University Medical Center
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Henderson、North Carolina、アメリカ、27536
- Maria Parham Medical Center
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Laurinburg、North Carolina、アメリカ、28352
- Scotland Memorial Hospital
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Lumberton、North Carolina、アメリカ、28359
- Southeastern Regional
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Raleigh、North Carolina、アメリカ、27609
- Duke Raleigh Hospital
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Salisbury、North Carolina、アメリカ、28144
- W. G. 'Bill' Hefner VA Medical Center
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Smithfield、North Carolina、アメリカ、27577
- Johnston Memorial Hospital
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Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest University
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South Carolina
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Spartanburg、South Carolina、アメリカ、29303
- Spartanburg Regional
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Virginia
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Hampton、Virginia、アメリカ、23666
- Virginia Oncology Associates
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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
18年歳以上 (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:
- Male, age ≥ 18 years
- Karnofsky performance status ≥ 70
- Life expectancy of ≥ 12 months
- Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken, and should be able to swallow tablets whole, without crushing/chewing tablets
- Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate
- Adequate laboratory parameters
- Histologically confirmed diagnosis of adenocarcinoma of the prostate. Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are excluded
- Radiographic evidence of metastatic disease; evaluable non-target lesions and/or bone only metastasis are permitted
- Ongoing ADT using an LHRH agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed. Screening serum testosterone must be <50 ng/dl
- PSA ≥ 2.0 ng/mL
Evidence of of castration resistant disease on ADT as evidenced by one of the following:
- Absolute rise in PSA of 2.0 ng/mL or greater, minimum 2 consecutive rising PSA levels with an interval of ≥ 1 week between each PSA level, OR
- 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, OR
- CT or MRI based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to modified PCWG2 criteria or modified RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies)
- A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide)
- A minimum of 4 weeks elapsed off of sipuleucel-T prior to start of study drug
- A minimum of 4 weeks from any major surgery prior to start of study drug
- Self-reported race of either African American or Caucasian
- Ability to swallow, retain, and absorb oral medication
Exclusion Criteria:
- Prior treatment with abiraterone acetate or enzalutamide
- Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
- Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid
- Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients
- Pathological finding consistent with small cell carcinoma of the prostate
- Symptomatic Liver or visceral organ metastasis
- Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
- Known brain metastasis
- Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
- Previously treated with ketoconazole for prostate cancer for greater than 7 days
- Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
- Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
- Poorly controlled diabetes
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline
- Atrial Fibrillation or other cardiac arrhythmia requiring therapy
- Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
- Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1
- Any condition which, in the opinion of the investigator, would preclude participation in this trial
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：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 |
|---|---|
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実験的：Abiraterone Acetate and Prednisone
abiraterone acetate will be administered by the patient at a dose of 1000mg orally once daily with prednisone 5 mg BID in 4-week cycles
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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 |
|---|---|---|
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Median Radiographic Progression Free Survival (PFS)
時間枠：up to 2 years
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Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Working Group 2 criteria, or to death due to any cause.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date.
Median rPFS was estimated using a Kaplan-Meier curve.
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up to 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 |
|---|---|---|
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Change in PSA Response
時間枠：Baseline and up to 2 years
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Percent of men with Prostate Specific Antigen (PSA) declines > 30%, > 50% and > 90%
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Baseline and up to 2 years
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Median Time to PSA Progression
時間枠：up to 2 years
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Time to PSA progression as defined by PCWG 2 criteria is the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.
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up to 2 years
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Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml
時間枠：up to 2 years
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Number of men who achieve a PSA decline to < 0.1 and < 0.2 ng/ml
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up to 2 years
|
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Percent of Subjects Experiencing Hypertension
時間枠：up to 2 years
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Incidence and grade of hypertension in the two populations.
(Grade 1: Systolic BP 120 to 139 mmHg or diastolic BP 80 to 89 mmHg, Grade 2: Systolic BP 140 to 159 mmHg or diastolic BP 90 to 99 mmHg, Grade 3: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg, Grade 4: Life-threatening consequences, urgent intervention indicated)
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up to 2 years
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Overall Survival
時間枠：up to 3 years
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Length of patient's life after starting study
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up to 3 years
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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。
スポンサー
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 (実際)
2013年10月1日
一次修了 (実際)
2019年10月8日
研究の完了 (実際)
2019年10月8日
試験登録日
最初に提出
2013年9月9日
QC基準を満たした最初の提出物
2013年9月11日
最初の投稿 (見積もり)
2013年9月12日
学習記録の更新
投稿された最後の更新 (実際)
2020年12月9日
QC基準を満たした最後の更新が送信されました
2020年11月16日
最終確認日
2020年11月1日
詳しくは
本研究に関する用語
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。