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Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
RECRUITINGSponsored by Hospital Moinhos de Vento
Actively Recruiting
SponsorHospital Moinhos de Vento
Started2022-08-19
Est. completion2026-10
Eligibility
Age18 Years – 78 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05343936
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
Age: 18 Years – 78 YearsSex: MALEHealthy volunteers accepted
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
Conditions2
CancerProstate Cancer
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Actively Recruiting
SponsorHospital Moinhos de Vento
Started2022-08-19
Est. completion2026-10
Eligibility
Age18 Years – 78 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05343936