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Trial record 1 of 1 for:    NCT04962919
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Survival Outcomes in Metastatic Prostate Cancer in the Brazilian Population - Analysis of Individual Characteristics and Treatment Modalities in Different National Health Institutions. (LACOG 1818)

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ClinicalTrials.gov Identifier: NCT04962919
Recruitment Status : Recruiting
First Posted : July 15, 2021
Last Update Posted : August 23, 2022
Sponsor:
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group

Study Description
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Brief Summary:
Survival outcomes in metastatic prostate cancer in the population Brazilian - analysis of individual characteristics and modalities of treatment in different national health institutions

Condition or disease
Prostatic Neoplasms, Castration-Resistant

Study Design
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Study Type : Observational
Estimated Enrollment : 590 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Survival Outcomes in Metastatic Prostate Cancer in the Brazilian Population - Analysis of Individual Characteristics and Treatment Modalities in Different National Health Institutions.
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort
Public institution
Castration-resistant metastatic prostate cancer diagnosed between January 2014 and December 2017
Private institution
Castration-resistant metastatic prostate cancer diagnosed between January 2014 and December 2017


Outcome Measures
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Primary Outcome Measures :
  1. Describe cause-specific survival in patients with castration-resistant prostate cancer in different institutions in Brazil. [ Time Frame: December of 2017 ]

Secondary Outcome Measures :
  1. To describe the sociodemographic characteristics of patients with castration-resistant metastatic prostate cancer in Brazil; [ Time Frame: December of 2017 ]
  2. To describe comorbidities of patients with castration-resistant metastatic prostate cancer in Brazil; [ Time Frame: December of 2017 ]
  3. To describe the clinicopathological characteristics of patients with metastatic castration-resistant prostate cancer in Brazil; [ Time Frame: December of 2017 ]
  4. To compare overall survival among patients with castration-resistant metastatic prostate cancer treated in the SUS and in the private network; [ Time Frame: December of 2017 ]
  5. To compare the treatments performed by patients with castration-resistant metastatic prostate cancer in the SUS and in the private network; [ Time Frame: December of 2017 ]
  6. To describe the rates of skeletal-related complications [ Time Frame: December of 2017 ]
  7. To describe the rate of admissions [ Time Frame: December of 2017 ]
  8. To describe the number of lines of treatment that patients have undergone [ Time Frame: December of 2017 ]
  9. To describe the presence or absence of treatments bone-directed [ Time Frame: December of 2017 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of castration-resistant metastatic prostate cancer diagnosed in the period between January 2014 and December 2017.
Criteria

Inclusion Criteria:

  • Diagnosis of castration-resistant metastatic prostate cancer diagnosed in the period between January 2014 and December 2017.

Exclusion Criteria:

  • Diagnosis of localized or locally advanced or metastatic disease sensitive to castration;
  • Patients with medical records filled with incomplete data that make it impossible to evaluate the treatment received.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04962919


Contacts
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Contact: Fernando Maluf, MD +55 11 3505 6612 maluffc@uol.com.br
Contact: Gustavo Werutsky, MD +55 51 33845334 gustavo.werutsky@lacog.org.br

Locations
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Brazil
CPO Pucrs Recruiting
Porto Alegre, RS, Brazil
Contact: André Fay         
Sírio Libanês Recruiting
São Paulo, SP, Brazil, 01308-050
Contact: Diogo Bastos         
A Real e Benemérita Associação Portuguesa de Beneficência Recruiting
São Paulo, SP, Brazil, 01323-001
Contact: Fernando Maluf, MD    +55 11 3505 6612    maluffc@uol.com.br   
Centro Paulista de Oncologia Recruiting
São Paulo, SP, Brazil
Contact: Andrey Soares         
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO Recruiting
Santo André, São Paulo, Brazil, 09060-650
Contact: Suelen Patricia dos Santos Martins, MD    4993-5491    suelen.martins@cepho.org.br   
Hospital Santa Marcelina Recruiting
São Paulo, Brazil, (11) 2070-6000
Contact: Roberto Odebrecht Rocha, MD    55 11 22173766    robertoodebrecht@hotmail.com   
Irmandade da Santa Casa de Misericórdia de São Paulo - Hospital Central Recruiting
São Paulo, Brazil, 01221-010
Contact: Deusdedit Cortez Vieira da Silva Neto, MD    +55 (11)98339-9974    vieiradasilva@gmail.com   
A.C.Camargo Cancer Center Recruiting
São Paulo, Brazil, 01525-001
Contact: José Augusto Rinck Júnior, MD    11 2189-5138    jose.rinck@accamargo.org.br   
Sponsors and Collaborators
Latin American Cooperative Oncology Group
More Information
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Publications:

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Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT04962919    
Other Study ID Numbers: LACOG 1818
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: August 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Latin American Cooperative Oncology Group:
Prostatic Neoplasms
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases