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Search / Trial NCT05343936

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

Launched by HOSPITAL MOINHOS DE VENTO · Apr 19, 2022

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Active Surveillance

ClinConnect Summary

This clinical trial is studying how well an active surveillance approach works for men with low-risk prostate cancer in Brazil. Active surveillance means that instead of starting treatment right away, doctors monitor the patient's condition closely to see if the cancer changes or worsens. The goal of the study is to gather important information about how often patients need treatment and how long they can stay healthy without it.

To be eligible for this trial, participants must be men diagnosed with prostate adenocarcinoma, which is a common type of prostate cancer. They should have a specific test result showing a low level of prostate-specific antigen (PSA) and a low Gleason score, which helps determine the aggressiveness of the cancer. Participants can expect regular check-ups and tests to monitor their cancer over time. This research is important because it aims to validate the active surveillance strategy in Brazil, potentially helping many men manage their prostate cancer more effectively without immediate treatment.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Pathological diagnosis of prostate adenocarcinoma;
  • Prostate biopsy with at least 12 cores;
  • PSA less than or equal to 10 ng/ml and clinical stage cT1/cT2a;
  • Gleason score below or equal to 6 (3+3);
  • Prostate multi parametric MRI performed or planned
  • Availability of pathological samples
  • Exclusion Criteria:
  • Clinical contraindication to prostatectomy and/or radiotherapy procedures;
  • Life expectancy below 10 years, according to the Charlson Comorbidity Index (ICC);
  • Previous treatment with hormone blockade or radical therapies.
  • Intraductal or cribriform histology on biopsy

About Hospital Moinhos De Vento

Hospital Moinhos de Vento is a leading healthcare institution based in Porto Alegre, Brazil, renowned for its commitment to excellence in patient care and medical research. With a strong focus on innovation and advancing clinical knowledge, the hospital actively sponsors a variety of clinical trials across multiple specialties. Its state-of-the-art facilities and multidisciplinary team of experts facilitate rigorous research protocols, ensuring the highest standards of safety and efficacy. By collaborating with academic institutions and industry partners, Hospital Moinhos de Vento strives to contribute to the development of new therapies and improve health outcomes for patients both locally and globally.

Locations

Porto Alegre, Rio Grande Do Sul, Brazil

Porto Alegre, Rio Grande Do Sul, Brazil

Belem, Para, Brazil

Curitiba, Parana, Brazil

Fortaleza, , Brazil

Porto Alegre, Rio Grande Do Sul, Brazil

Salvador, Bahia, Brazil

Pelotas, Rio Grande Do Sul, Brazil

Salvador, Bahia, Brazil

Fortaleza, Ceará, Brazil

Vitoria, Espirito Santo, Brazil

Belo Horizonte, Minas Gerais, Brazil

Rio Grande, Rio Grande Do Sul, Brazil

Barretos, Sao Paulo, Brazil

Brasilia, Distrito Federal, Brazil

São Paulo, Sao Paulo, Brazil

Patients applied

0 patients applied

Trial Officials

Pedro Henrique Isaacsson Velho, M.D.

Principal Investigator

Head of Clinical Research

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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