Status:

RECRUITING

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

Lead Sponsor:

Hospital Moinhos de Vento

Conditions:

Prostate Cancer

Eligibility:

MALE

18-78 years

Brief 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...

Detailed 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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 19 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

490 Patients enrolled

Trial Details

Trial ID

NCT05343936

Start Date

August 19 2022

End Date

December 1 2026

Last Update

January 18 2024

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Oncocentro Ceará

Fortaleza, Ceará, Brazil, 60135-237

2

Hospital Universitário Cassiano Antônio Moraes

Vitória, Espírito Santo, Brazil

3

Hospital Obras de Caridade Irma Dulce

Salvador, Estado de Bahia, Brazil, 40.415-006

4

Hospital Santa Izabel

Salvador, Estado de Bahia, Brazil, 40050-410