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

NCT05343936 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 490

Last updated 2026-03-18

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Hospital Moinhos de Vento

    lead OTHER

Principal Investigators

  • Pedro Henrique Isaacsson Velho, M.D. · Head of Clinical Research

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05343936 on ClinicalTrials.gov