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Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
Sponsor: Hospital Moinhos de Vento
Summary
In this study, the investigators aim to form a Brazilian national prospective active surveillance cohort of patients with low-risk prostate cancer in the public health system. The investigators aim to demonstrate data on the pathological reclassification rate, treatment-free survival, among others. This cohort aim to evaluate and validate the active surveillance strategy in Brazil.
Key Details
Gender
MALE
Age Range
18 Years - 78 Years
Study Type
OBSERVATIONAL
Enrollment
490
Start Date
2022-08-15
Completion Date
2026-12
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Active surveillance
The active surveillance protocol involves a TRUS prostate biopsy at eligibility, at 12 months and then every two years. MRI with or without biopsy at eligibility and then every two years. Clinical evaluation with digital rectal examination and PSA every 6 months. Every year a quality of life and anxiety evaluation are planned. A new prostate biopsy is indicated if biochemical progression by PSA or changes in multiparametric MRI. Triggers for definitive intervention are biopsy pathological reclassification with Gleason score greater than 6, clinical progression or patient's request.
Locations (15)
Oncocentro Ceará
Fortaleza, Ceará, Brazil
Hospital Universitário Cassiano Antônio Moraes
Vitória, Espírito Santo, Brazil
Hospital Obras de Caridade Irma Dulce
Salvador, Estado de Bahia, Brazil
Hospital Santa Izabel
Salvador, Estado de Bahia, Brazil
Hospital Universitario de Brasilia
Brasília, Federal District, Brazil
Hospital Mario Penna
Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital Universitario Joao de Barros Barreto
Belém, Pará, Brazil
Hospital Escola - UFPEL
Pelotas, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Universidade Dr. Miguel Riet Corrêa Jr.
Rio Grande, Rio Grande do Sul, Brazil
Hospital de Amor
Barretos, São Paulo, Brazil
IAMSPE
São Paulo, São Paulo, Brazil