- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02230059
Study to Assess the Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC) (REALIST-PRO)
24. september 2014 opdateret af: Janssen Research & Development, LLC
Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC): Real Life Analysis In Brazilian Oncology Centers (REALIST-PRO)
The purpose of this study is to assess the treatment patterns in participants with metastatic castration-resistant prostate cancer (mCRPC).
Additionally, participant's demographic and clinical characteristics, skeletal-related events, criteria used to define CRPC, prostate specific antigen (PSA) levels and pain related to disease and overall survival will be observed.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is an observational (study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes), longitudinal (correlational research study that involves repeated observations of the same variables over long periods of time) and retrospective (study looking back over past experience) study to describe the treatment patterns in mCRPC.
Treatment patterns will be assessed by collecting medical charts from participants diagnosed with mCRPC in or prior 2009.
Primarily, percentage of participants who received therapy as first line treatment will be assessed.
All adverse events associated with the use of Sponsor drugs will be reported.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
382
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Brasilia, Brasilien
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Curitiba, Brasilien
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Distrito Federal, Brasilien
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Florianopolis, Brasilien
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Goiania, Brasilien
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Ijuí, Brasilien
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Jau, Brasilien
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Porto Alegre, Brasilien
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Rio De Janeiro, Brasilien
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Sao Paulo, Brasilien
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Male participants with history of prostatic cancer and metastatic castration-resistant prostate cancer (mCRPC) from Brazil will be assessed.
Beskrivelse
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Report of previous surgical or medical castration
- Castration-resistant prostate cancer (CRPC) diagnosis in or before 2009
- Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography or magnetic resonance imaging in or before 2009. If lymph node metastasis is the only evidence of metastasis, it must be 2 centimeters (cm) in diameter
Exclusion Criteria:
- Participation in any investigational drug or device study or early access programme
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Metastatic Castration-resistant Prostate Cancer
Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.
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Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants Treated With Chemotherapy in First Line Therapy
Tidsramme: Day 1
|
Participants treated with chemotherapy in first line therapy will be reported.
|
Day 1
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Percentage of Participants Treated With Other Therapies in First Line Therapy
Tidsramme: Day 1
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Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in first line therapy will be reported.
|
Day 1
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Percentage of Participants Treated With Chemotherapy in Second Line Therapy
Tidsramme: Day 1
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Participants who were treated with chemotherapy in second line therapy will be reported.
|
Day 1
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Percentage of Participants Treated With Other Therapies in Second Line Therapy
Tidsramme: Day 1
|
Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in second line therapy will be reported.
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Day 1
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Tidsramme: Day 1
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ECOG performance status is a scale that measures how cancer affects the daily life of a participant on an ordinal scale from grade 0 (best) to grade 5 (worst).
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Day 1
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Number of Participants with Comorbidities
Tidsramme: Day 1
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Participants with comorbidities such as hypertension, diabetes, cardiac diseases, congestive cardiac failure, thyroid diseases and stroke will be reported.
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Day 1
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Blood Prostate Specific Antigen (PSA) levels
Tidsramme: Day 1
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Blood PSA levels will be reported.
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Day 1
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Number of participants With Bone or Visceral Metastasis
Tidsramme: Day 1
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Participants with bone or visceral metastasis will be reported.
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Day 1
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Assessment of Pain Related With Disease
Tidsramme: Day 1
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Pain will be assessed by reviewing the charts having information regarding pain (bone or other sites).
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Day 1
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Number of Participants With Gleason score
Tidsramme: Day 1
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Gleason scoring is used to grade tumors.
A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern.
The two grades are added together to get a GS.
Gleason grade range= 1-5; 5=worst prognosis.
GS range=2-10; 10=worst prognosis.
Improvement is defined as a decrease in GS from a Baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).
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Day 1
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Percentage of Participants With Skeletal Related Events (SREs)
Tidsramme: Day 1
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SREs include vertebral collapse, bone fractures, spinal cord compression, bone surgery and radiotherapy for bone complications.
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Day 1
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Number of Participants who were used to define mCRPC Criteria
Tidsramme: Day 1
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Participants with criteria used to define mCRPC as described by European Association of Urology (EAU) International Guidelines will be reported.
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Day 1
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Percentage of Participants Who Received Therapies After Second Line
Tidsramme: Day 1
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Participants who received therapies after second line will be reported.
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Day 1
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Overall Survival
Tidsramme: Day 1
|
Day 1
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2013
Primær færdiggørelse (Faktiske)
1. maj 2014
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
29. august 2014
Først indsendt, der opfyldte QC-kriterier
29. august 2014
Først opslået (Skøn)
3. september 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. september 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. september 2014
Sidst verificeret
1. september 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR100943
- 212082PCR0001 (Anden identifikator: Janssen Research & Development, LLC)
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