Clinical trial NCT02230059: Study to Assess the Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC)
Official title: Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC): Real Life Analysis In Brazilian Oncology Centers (REALIST-PRO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: Prostatic Neoplasms
observational Study
Metastatic castration-resistant prostate cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 382
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male participants with history of prostatic cancer and metastatic castration-resistant prostate cancer (mCRPC) from Brazil will be assessed.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Treated With Chemotherapy in First Line Therapy
timeFrame: Day 1
measure: Percentage of Participants Treated With Other Therapies in First Line Therapy
timeFrame: Day 1
measure: Percentage of Participants Treated With Chemotherapy in Second Line Therapy
timeFrame: Day 1
measure: Percentage of Participants Treated With Other Therapies in Second Line Therapy
timeFrame: Day 1
Secondary outcomes:
measure: Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Day 1
measure: Number of Participants with Comorbidities
timeFrame: Day 1
measure: Blood Prostate Specific Antigen (PSA) levels
timeFrame: Day 1
measure: Number of participants With Bone or Visceral Metastasis
timeFrame: Day 1
measure: Assessment of Pain Related With Disease
timeFrame: Day 1
measure: Number of Participants With Gleason score
timeFrame: Day 1
measure: Percentage of Participants With Skeletal Related Events (SREs)
timeFrame: Day 1
measure: Number of Participants who were used to define mCRPC Criteria
timeFrame: Day 1
measure: Percentage of Participants Who Received Therapies After Second Line
timeFrame: Day 1
measure: Overall Survival
timeFrame: Day 1
Other outcomes:
Locations:
city: Brasilia
country: Brazil
city: Curitiba
country: Brazil
city: Distrito Federal
country: Brazil
city: Florianopolis
country: Brazil
city: Goiania
country: Brazil
city: Ijuí
country: Brazil
city: Jau
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: