A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (TOGETHER)
6. února 2017 aktualizováno: 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.
Přehled studie
Postavení
Staženo
Podmínky
Typ studie
Pozorovací
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Mužský
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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).
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants Complaint With Treatment (Compliance Rate)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Suspension of mCRPC Participants Treated With AA + P
Časové okno: Month 12/ early withdrawal
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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
Časové okno: Month 12/ early withdrawal
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
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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
Časové okno: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
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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
Časové okno: Baseline, Months 3, 6, 9, 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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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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Baseline, Months 3, 6, 9, 12/ early withdrawal
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Overall Survival (OS)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2016
Primární dokončení (Očekávaný)
1. srpna 2017
Dokončení studie (Očekávaný)
1. dubna 2018
Termíny zápisu do studia
První předloženo
14. září 2016
První předloženo, které splnilo kritéria kontroly kvality
14. září 2016
První zveřejněno (Odhad)
19. září 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
8. února 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
6. února 2017
Naposledy ověřeno
1. února 2017
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CR108078
- 212082PCR4035 (Jiný identifikátor: Janssen Research & Development, LLC)
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