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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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