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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

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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