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Prostatic NeoplasmsREALIST-PRONCT02230059

Study to Assess the Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC)

An observational study of Prostatic Neoplasms, run by Janssen Research & Development, LLC at 10 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
How many people
382 participants
Where
10 sitesBrazil
Study dates
Jul 2013to May 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Brazil10 sites

  • Study site

    Brasília

  • Study site

    Curitiba

  • Study site

    Distrito Federal

  • Study site

    Florianópolis

  • Study site

    Goiânia

  • Study site

    Ijuí

  • Study site

    Jaú

  • Study site

    Porto Alegre

  • Study site

    Rio de Janeiro

  • Study site

    São Paulo

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
No Intervention
Keywords
Prostatic Neoplasms, observational Study, Metastatic castration-resistant prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

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

Study groups in NCT02230059
Study groupRoleWhat they receive
Metastatic Castration-resistant Prostate CancerMedical charts of participants with metastatic castration-resistant prostate cancer will be observed.
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Treated With Chemotherapy in First Line Therapy

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

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. Percentage of Participants Treated With Chemotherapy in Second Line Therapy

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

    Measured: Day 1

  4. 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.

    Measured: Day 1

Secondary outcomes (10)

  1. Eastern Cooperative Oncology Group (ECOG) Performance Status

    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).

    Measured: Day 1

  2. Number of Participants with Comorbidities

    Participants with comorbidities such as hypertension, diabetes, cardiac diseases, congestive cardiac failure, thyroid diseases and stroke will be reported.

    Measured: Day 1

  3. Blood Prostate Specific Antigen (PSA) levels

    Blood PSA levels will be reported.

    Measured: Day 1

  4. Number of participants With Bone or Visceral Metastasis

    Participants with bone or visceral metastasis will be reported.

    Measured: Day 1

  5. Assessment of Pain Related With Disease

    Pain will be assessed by reviewing the charts having information regarding pain (bone or other sites).

    Measured: Day 1

  6. Number of Participants With Gleason score

    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).

    Measured: Day 1

  7. Percentage of Participants With Skeletal Related Events (SREs)

    SREs include vertebral collapse, bone fractures, spinal cord compression, bone surgery and radiotherapy for bone complications.

    Measured: Day 1

  8. Number of Participants who were used to define mCRPC Criteria

    Participants with criteria used to define mCRPC as described by European Association of Urology (EAU) International Guidelines will be reported.

    Measured: Day 1

  9. Percentage of Participants Who Received Therapies After Second Line

    Participants who received therapies after second line will be reported.

    Measured: Day 1

  10. Overall Survival

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2014 (estimated)
  2. Study startJul 2013
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
382 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02230059
Sponsor's protocol ID
CR100943
Other IDs
212082PCR0001
Acronym
REALIST-PRO
Status last verified
Sep 2014
First submitted
29 Aug 2014
Last updated
25 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostatic Neoplasms, run by Janssen Research & Development, LLC at 10 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Treated With Chemotherapy in First Line Therapy (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02230059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.

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