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

Last updated: January 16, 2024
Sponsor: Hospital Moinhos de Vento
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Urologic Cancer

Prostate Disorders

Treatment

Active surveillance

Clinical Study ID

NCT05343936
56352622.8.1001.5330
  • Ages 18-78
  • Male

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 490
Treatment Group(s): 1
Primary Treatment: Active surveillance
Phase:
Study Start date:
August 19, 2022
Estimated Completion Date:
December 31, 2026

Study Description

Prostate cancer is the most common malignancy in men in Brazil. It is estimated that about 80% of patients diagnosed with prostate cancer have localized disease, and many of these cases have low-risk cancer.

Active surveillance(AS) is a treatment strategy mainly for low risk prostate cancer to avoid radical treatment through periodic assessments (PSA, digital rectal exam and Prostatic Biopsies). During this follow-up, the patient will be treated only when necessary and with curative intent. Several series of institutional cohorts with long-term follow-up have demonstrated that the AS strategy in selected patients is a safe alternative to immediate treatment, with comparable survival.

The active surveillance strategy has never been evaluated in the Brazilian population. The main outcomes from AS derive from international cohorts. The Brazilian population is extremely diverse, so validation in this cohort is relevant. The current study aim to form a national multicentric prospective cohort of patients with low-risk prostate cancer following an AS protocol in the the public health system to evaluate and validate this strategy in Brazil.

Connect with a study center

  • Hospital Obras de Caridade Irma Dulce

    Salvador, Bahia 40.415-006
    Brazil

    Active - Recruiting

  • Hospital Santa Izabel

    Salvador, Bahia 40050-410
    Brazil

    Active - Recruiting

  • Oncocentro Ceará

    Fortaleza, Ceará 60135-237
    Brazil

    Active - Recruiting

  • Hospital Universitario de Brasilia

    Brasilia, Distrito Federal
    Brazil

    Active - Recruiting

  • Hospital Universitário Cassiano Antônio Moraes

    Vitoria, Espirito Santo
    Brazil

    Active - Recruiting

  • Hospital Mario Penna

    Belo Horizonte, Minas Gerais
    Brazil

    Active - Recruiting

  • Hospital Universitario Joao de Barros Barreto

    Belem, Para 66073-000
    Brazil

    Active - Recruiting

  • Hospital Erasto Gaertner

    Curitiba, Parana
    Brazil

    Active - Recruiting

  • Hospital Escola - UFPEL

    Pelotas, Rio Grande Do Sul
    Brazil

    Active - Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande Do Sul 90035-000
    Brazil

    Active - Recruiting

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, Rio Grande Do Sul
    Brazil

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul
    Brazil

    Active - Recruiting

  • Hospital Universidade Dr. Miguel Riet Corrêa Jr.

    Rio Grande, Rio Grande Do Sul
    Brazil

    Active - Recruiting

  • Hospital de Amor

    Barretos, Sao Paulo 14784-400
    Brazil

    Active - Recruiting

  • IAMSPE

    São Paulo, Sao Paulo
    Brazil

    Active - Recruiting

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