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ACTIVE NOT RECRUITING
NCT05343936

Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population

Sponsor: Hospital Moinhos de Vento

View on ClinicalTrials.gov

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

OTHER

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