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Brazilian study tests active surveillance for Low-Risk prostate cancer

NCT ID NCT05343936

Knowledge-focused Sponsor: Hospital Moinhos de Vento Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 490 men with low-risk prostate cancer in Brazil to see how well active surveillance works. Active surveillance means closely monitoring the cancer instead of treating it right away. The goal is to learn how often the cancer changes and how many men avoid treatment over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 490 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Brazilian men with prostate adenocarcinoma with localized and low-risk disease. They should be attending in the public healthcare system and being treated by the active surveillance protocol.

Ages

18 to 78 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Hospital Erasto Gaertner

    Curitiba, Paraná, Brazil

  • Hospital Escola - UFPEL

    Pelotas, Rio Grande do Sul, Brazil

  • Hospital Mario Penna

    Belo Horizonte, Minas Gerais, Brazil

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-000, Brazil

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, Rio Grande do Sul, Brazil

  • Hospital Obras de Caridade Irma Dulce

    Salvador, Estado de Bahia, 40.415-006, Brazil

  • Hospital Santa Izabel

    Salvador, Estado de Bahia, 40050-410, Brazil

  • Hospital Universidade Dr. Miguel Riet Corrêa Jr.

    Rio Grande, Rio Grande do Sul, Brazil

  • Hospital Universitario Joao de Barros Barreto

    Belém, Pará, 66073-000, Brazil

  • Hospital Universitario de Brasilia

    Brasília, Federal District, Brazil

  • Hospital Universitário Cassiano Antônio Moraes

    Vitória, Espírito Santo, Brazil

  • Hospital de Amor

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, Brazil

  • IAMSPE

    São Paulo, São Paulo, Brazil

  • Oncocentro Ceará

    Fortaleza, Ceará, 60135-237, Brazil

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