Spots Global Cancer Trial Database for Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
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Trial Identification
Brief Title: Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
Official Title: Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
Study ID: NCT05343936
Conditions
Interventions
Study Description
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 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.
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 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Hospital Obras de Caridade Irma Dulce, Salvador, Bahia, Brazil
Hospital Santa Izabel, Salvador, Bahia, Brazil
Oncocentro Ceará, Fortaleza, Ceará, Brazil
Hospital Universitario de Brasilia, Brasilia, Distrito Federal, Brazil
Hospital Universitário Cassiano Antônio Moraes, Vitoria, Espirito Santo, Brazil
Hospital Mario Penna, Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner, Curitiba, Parana, Brazil
Hospital Universitario Joao de Barros Barreto, Belem, Para, Brazil
Hospital Escola - UFPEL, Pelotas, Rio Grande Do Sul, Brazil
Hospital Moinhos de Vento, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora da Conceição, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Universidade Dr. Miguel Riet Corrêa Jr., Rio Grande, Rio Grande Do Sul, Brazil
Hospital de Amor, Barretos, Sao Paulo, Brazil
IAMSPE, São Paulo, Sao Paulo, Brazil
Contact Details
Name: Pedro Henrique Isaacsson Velho, M.D.
Affiliation: Head of Clinical Research
Role: PRINCIPAL_INVESTIGATOR
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