NCT04962919

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
active not recruiting

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

January 14, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

5.3 years

First QC Date

June 24, 2021

Last Update Submit

February 10, 2025

Conditions

Keywords

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Describe cause-specific survival in patients with castration-resistant prostate cancer in different institutions in Brazil.

    December of 2017

Secondary Outcomes (9)

  • To describe the sociodemographic characteristics of patients with castration-resistant metastatic prostate cancer in Brazil;

    December of 2017

  • To describe comorbidities of patients with castration-resistant metastatic prostate cancer in Brazil;

    December of 2017

  • To describe the clinicopathological characteristics of patients with metastatic castration-resistant prostate cancer in Brazil;

    December of 2017

  • To compare overall survival among patients with castration-resistant metastatic prostate cancer treated in the SUS and in the private network;

    December of 2017

  • To compare the treatments performed by patients with castration-resistant metastatic prostate cancer in the SUS and in the private network;

    December of 2017

  • +4 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CPO Pucrs

Porto Alegre, Rio Grande do Sul, Brazil

Location

Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO

Santo André, São Paulo, 09060-650, Brazil

Location

Sírio Libanês

São Paulo, São Paulo, 01308-050, Brazil

Location

Centro Paulista de Oncologia

São Paulo, São Paulo, Brazil

Location

Hospital Santa Marcelina

São Paulo, (11) 2070-6000, Brazil

Location

BP - A Beneficência Portuguesa de São Paulo

São Paulo, 01.323-030, Brazil

Location

Irmandade da Santa Casa de Misericórdia de São Paulo - Hospital Central

São Paulo, 01221-010, Brazil

Location

A.C.Camargo Cancer Center

São Paulo, 01525-001, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-ResistantProstatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fernando Cotait Maluf

    Latin American Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 15, 2021

Study Start

January 14, 2020

Primary Completion

May 7, 2025

Study Completion

May 7, 2025

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations