A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (TOGETHER)
2017年2月6日 更新者：Janssen Research & Development, LLC
A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Exposed to Abiraterone Acetate (TOGETHER)
The primary purpose of this study is to determine the rate of compliance to abiraterone acetate and prednisone (AA + P) treatment in Colombian Castration-resistant metastatic prostate cancer (mCRPC) participants experiencing adequate response to treatment, in a real-world clinical setting.
調査の概要
状態
引きこもった
条件
研究の種類
観察的
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
サンプリング方法
非確率サンプル
調査対象母集団
Participants enrolled in this study will be men with mCRPC currently receiving AA + P for at least 1 cycle before study enrollment, and to a maximum of 4 cycles (4 months).
説明
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Distant metastatic disease documented by positive bone scan or metastatic lesions on computerized tomography (CT) or magnetic resonance imaging (MRI)
- Prescribed and currently (at enrollment) being treated with abiraterone acetate and prednisone (AA + P) for the treatment of Castration-resistant metastatic prostate cancer (mCRPC) according to the local product label
- Having received a minimum 1 cycle of AA + P (4 weeks), and maximum 4 consecutive cycles of AA + P (16 weeks ) prior to study enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2 at enrollment
Exclusion Criteria:
- Participants who have received and terminated abiraterone acetate treatment for prostate cancer (PCa) in the past
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device less than or equal to (<=) 30 days before the start of the study or the first data collection time point
- Presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the abiraterone acetate treatment in mCRPC
- Known brain metastases
- Pathological finding consistent with small cell carcinoma of the prostate
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
コホートと介入
グループ/コホート |
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mCRPC participants
Participants will not receive any intervention as a part of this study.
Participants with Metastatic Castration Resistant Prostate Cancer (mCRPC) who have adequate response to treatment (abiraterone Acetate + prednisone) will be observed to collect data for ECOG performance status, safety assessments (as described above), the collection of PROs (BPI-short form, Pain VAS, HCU questionnaire), the assessment of disease status and parameters, and the assessment of participant compliance to treatment.
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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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Percentage of Participants Complaint With Treatment (Compliance Rate)
時間枠：Month 12/ early withdrawal
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Percentage of participants who are compliant to abiraterone acetate and prednisone (AA + P) treatment in Colombian mCRPC participants experiencing adequate response to treatment will be assessed.
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Month 12/ early withdrawal
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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 |
|---|---|---|
|
Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Suspension of mCRPC Participants Treated With AA + P
時間枠：Month 12/ early withdrawal
|
Treatment suspension will be defined as the interruption of drug administration (abiraterone acetate) for two or more cycles of administration.
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Month 12/ early withdrawal
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Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Abandonment of mCRPC Participants Treated With AA + P
時間枠：Month 12/ early withdrawal
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Treatment abandonment will be defined as patient-driven cessation of drug administration, regardless of causality.
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Month 12/ early withdrawal
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Utilization of Health Care Resources, as Measured by the Consumption of Health Care Resources Questionnaire
時間枠：Baseline, Months 3, 6, 9, 12/ early withdrawal
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Utilization of Health Care Resources will be measured by the Consumption of Health Care Resources Questionnaire, which includes questions related to the participant's use of health care resources related to Prostate cancer PCa: 1) Insurance type, 2) Extra or unscheduled visits to the study doctor, another physician/specialist, healthcare professional (like nurse, therapist, physiotherapist), 3) Admission to a hospital, 4) Visits to a hospital emergency room, 5) Use of an ambulance service, 6) Complementary alternative therapy visits.
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Baseline, Months 3, 6, 9, 12/ early withdrawal
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Change From AA + P Treatment Initiation in Patient Functionality Measured by the Eastern Cooperative Oncology Group (ECOG) Scale at Baseline, Months 3, 6, 9, and 12
時間枠：AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
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ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead.
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AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
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Change From AA + P Treatment Initiation in Prostate-Specific Antigen (PSA) Levels at Baseline, Months 3, 6, 9, and 12
時間枠：AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
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AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
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Change From AA + P Treatment Initiation in Patient Pain Assessed by the Brief Pain Inventory (BPI) at Baseline, Months 3, 6, 9, and 12
時間枠：AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
|
Pain intensity was assessed by Brief Pain Inventory Short Form (BPI-sf) on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.
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AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
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Change From AA + P Treatment Initiation in Patient Pain Assessed by the Pain Visual Analogue Scale (VAS) at Baseline, Months 3, 6, 9, and 12
時間枠：AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
|
VAS is a 100 millimeter (mm) scale.
Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.
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AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
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Change From Baseline in Patient Functionality Measured by the Eastern Cooperative Oncology Group (ECOG) Scale at Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12/ early withdrawal
|
ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead.
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Baseline, Months 3, 6, 9, 12/ early withdrawal
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Change From Baseline in Prostate-Specific Antigen (PSA) Levels at Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12/ early withdrawal
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Baseline, Months 3, 6, 9, 12/ early withdrawal
|
|
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Change From Baseline in Patient Pain Assessed by the Brief Pain Inventory (BPI) at Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12/ early withdrawal
|
Pain intensity was assessed by Brief Pain Inventory Short Form (BPI-sf) on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.
|
Baseline, Months 3, 6, 9, 12/ early withdrawal
|
|
Change From Baseline in Patient Pain Assessed by the Pain Visual Analogue Scale (VAS) at Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12/ early withdrawal
|
VAS is a 100 millimeter (mm) scale.
Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.
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Baseline, Months 3, 6, 9, 12/ early withdrawal
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Overall Survival (OS)
時間枠：Month 12
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The OS is defined as the time from the date of first dose of study drug to date of death from any cause.
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Month 12
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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。
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
2016年9月1日
一次修了 (予想される)
2017年8月1日
研究の完了 (予想される)
2018年4月1日
試験登録日
最初に提出
2016年9月14日
QC基準を満たした最初の提出物
2016年9月14日
最初の投稿 (見積もり)
2016年9月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2017年2月8日
QC基準を満たした最後の更新が送信されました
2017年2月6日
最終確認日
2017年2月1日
詳しくは
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