A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (TOGETHER)
6 lutego 2017 zaktualizowane przez: 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.
Przegląd badań
Status
Wycofane
Warunki
Typ studiów
Obserwacyjny
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Męski
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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).
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Participants Complaint With Treatment (Compliance Rate)
Ramy czasowe: Month 12/ early withdrawal
|
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.
|
Month 12/ early withdrawal
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Suspension of mCRPC Participants Treated With AA + P
Ramy czasowe: Month 12/ early withdrawal
|
Treatment suspension will be defined as the interruption of drug administration (abiraterone acetate) for two or more cycles of administration.
|
Month 12/ early withdrawal
|
|
Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Abandonment of mCRPC Participants Treated With AA + P
Ramy czasowe: Month 12/ early withdrawal
|
Treatment abandonment will be defined as patient-driven cessation of drug administration, regardless of causality.
|
Month 12/ early withdrawal
|
|
Utilization of Health Care Resources, as Measured by the Consumption of Health Care Resources Questionnaire
Ramy czasowe: Baseline, Months 3, 6, 9, 12/ early withdrawal
|
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.
|
Baseline, Months 3, 6, 9, 12/ early withdrawal
|
|
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
Ramy czasowe: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 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.
|
AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
|
|
Change From AA + P Treatment Initiation in Prostate-Specific Antigen (PSA) Levels at Baseline, Months 3, 6, 9, and 12
Ramy czasowe: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
|
AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
|
|
|
Change From AA + P Treatment Initiation in Patient Pain Assessed by the Brief Pain Inventory (BPI) at Baseline, Months 3, 6, 9, and 12
Ramy czasowe: 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.
|
AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
|
|
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
Ramy czasowe: 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.
|
AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
|
|
Change From Baseline in Patient Functionality Measured by the Eastern Cooperative Oncology Group (ECOG) Scale at Months 3, 6, 9, and 12
Ramy czasowe: 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.
|
Baseline, Months 3, 6, 9, 12/ early withdrawal
|
|
Change From Baseline in Prostate-Specific Antigen (PSA) Levels at Months 3, 6, 9, and 12
Ramy czasowe: Baseline, Months 3, 6, 9, 12/ early withdrawal
|
Baseline, Months 3, 6, 9, 12/ early withdrawal
|
|
|
Change From Baseline in Patient Pain Assessed by the Brief Pain Inventory (BPI) at Months 3, 6, 9, and 12
Ramy czasowe: 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
Ramy czasowe: 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
|
|
Overall Survival (OS)
Ramy czasowe: Month 12
|
The OS is defined as the time from the date of first dose of study drug to date of death from any cause.
|
Month 12
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 września 2016
Zakończenie podstawowe (Oczekiwany)
1 sierpnia 2017
Ukończenie studiów (Oczekiwany)
1 kwietnia 2018
Daty rejestracji na studia
Pierwszy przesłany
14 września 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 września 2016
Pierwszy wysłany (Oszacować)
19 września 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
8 lutego 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 lutego 2017
Ostatnia weryfikacja
1 lutego 2017
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CR108078
- 212082PCR4035 (Inny identyfikator: Janssen Research & Development, LLC)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .