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A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (TOGETHER)

6. februar 2017 oppdatert av: 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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Studietype

Observasjonsmessig

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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).

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Complaint With Treatment (Compliance Rate)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Suspension of mCRPC Participants Treated With AA + P
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Research & Development, LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2016

Primær fullføring (Forventet)

1. august 2017

Studiet fullført (Forventet)

1. april 2018

Datoer for studieregistrering

Først innsendt

14. september 2016

Først innsendt som oppfylte QC-kriteriene

14. september 2016

Først lagt ut (Anslag)

19. september 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR108078
  • 212082PCR4035 (Annen identifikator: Janssen Research & Development, LLC)

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