- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02230059
Study to Assess the Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC) (REALIST-PRO)
24 september 2014 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
382
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Male participants with history of prostatic cancer and metastatic castration-resistant prostate cancer (mCRPC) from Brazil will be assessed.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants Treated With Chemotherapy in First Line Therapy
Tidsram: Day 1
|
Participants treated with chemotherapy in first line therapy will be reported.
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Day 1
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Percentage of Participants Treated With Other Therapies in First Line Therapy
Tidsram: 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.
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Day 1
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Percentage of Participants Treated With Chemotherapy in Second Line Therapy
Tidsram: Day 1
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Participants who were treated with chemotherapy in second line therapy will be reported.
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Day 1
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Percentage of Participants Treated With Other Therapies in Second Line Therapy
Tidsram: 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 second line therapy will be reported.
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Day 1
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Day 1
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Day 1
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2013
Primärt slutförande (Faktisk)
1 maj 2014
Avslutad studie (Faktisk)
1 maj 2014
Studieregistreringsdatum
Först inskickad
29 augusti 2014
Först inskickad som uppfyllde QC-kriterierna
29 augusti 2014
Första postat (Uppskatta)
3 september 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
25 september 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 september 2014
Senast verifierad
1 september 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR100943
- 212082PCR0001 (Annan identifierare: Janssen Research & Development, LLC)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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