NCT02230059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

10 months

First QC Date

August 29, 2014

Last Update Submit

September 24, 2014

Conditions

Prostatic Neoplasms

Keywords

Prostatic Neoplasmsobservational StudyMetastatic castration-resistant prostate cancer

Outcome Measures

Primary Outcomes (4)

  • Percentage of Participants Treated With Chemotherapy in First Line Therapy

    Participants treated with chemotherapy in first line therapy will be reported.

    Day 1

  • Percentage of Participants Treated With Other Therapies in First Line Therapy

    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

  • Percentage of Participants Treated With Chemotherapy in Second Line Therapy

    Participants who were treated with chemotherapy in second line therapy will be reported.

    Day 1

  • Percentage of Participants Treated With Other Therapies in Second Line Therapy

    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.

    Day 1

Secondary Outcomes (10)

  • Eastern Cooperative Oncology Group (ECOG) Performance Status

    Day 1

  • Number of Participants with Comorbidities

    Day 1

  • Blood Prostate Specific Antigen (PSA) levels

    Day 1

  • Number of participants With Bone or Visceral Metastasis

    Day 1

  • Assessment of Pain Related With Disease

    Day 1

  • +5 more secondary outcomes

Study Arms (1)

Metastatic Castration-resistant Prostate Cancer

Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.

Other: No Intervention

Interventions

No InterventionOTHER

Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male participants with history of prostatic cancer and metastatic castration-resistant prostate cancer (mCRPC) from Brazil will be assessed.

You may qualify if:

  • 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

You may not qualify if:

  • Participation in any investigational drug or device study or early access programme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Brasília, Brazil

Location

Unknown Facility

Curitiba, Brazil

Location

Unknown Facility

Distrito Federal, Brazil

Location

Unknown Facility

Florianópolis, Brazil

Location

Unknown Facility

Goiânia, Brazil

Location

Unknown Facility

Ijuí, Brazil

Location

Unknown Facility

Jaú, Brazil

Location

Unknown Facility

Porto Alegre, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2014

First Posted

September 3, 2014

Study Start

July 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

BR(10)