Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
1 other identifier
observational
490
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 18, 2026
March 1, 2026
4.1 years
April 11, 2022
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biopsy pathological reclassification rate
Gleason score above 6 (min: 6 - max: 10) in prostate biopsy
12-month analysis
Secondary Outcomes (8)
Treatment-Free Survival rate
12-month and 24-month analysis
Overall survival rate
12-month and 24-month analysis
Cancer-Specific Mortality Rate
12-month and 24-month analysis
Metastasis-free survival rate
12-month and 24-month analysis
Quality of life evaluation
12-month and 24-month analysis
- +3 more secondary outcomes
Other Outcomes (2)
Monitoring of active surveillance harm
12-month and 24-month analysis
Evaluation of pathological outcomes in patients undergoing radical prostatectomy
12-month and 24-month analysis
Study Arms (1)
Active surveillance
This is a multicentric active surveillance prospective cohort study. The eligibility criteria defined are: low-risk prostate adenocarcinoma (clinical stage of cT1-T2a / Group Grade 1 (Gleason score less or equal to 6) / PSA less or equal to 10 ng/ml), transrectal prostate biopsy with at least 12 cores, estimated life expectancy over 10 years, clinical conditions for definitive treatment, multiparametric prostate MRI performed or planned.
Interventions
The active surveillance protocol involves a TRUS prostate biopsy at eligibility, at 12 months and then every two years. MRI with or without biopsy at eligibility and then every two years. Clinical evaluation with digital rectal examination and PSA every 6 months. Every year a quality of life and anxiety evaluation are planned. A new prostate biopsy is indicated if biochemical progression by PSA or changes in multiparametric MRI. Triggers for definitive intervention are biopsy pathological reclassification with Gleason score greater than 6, clinical progression or patient's request.
Eligibility Criteria
Brazilian men with prostate adenocarcinoma with localized and low-risk disease. They should be attending in the public healthcare system and being treated by the active surveillance protocol.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Oncocentro Ceará
Fortaleza, Ceará, 60135-237, Brazil
Hospital Universitário Cassiano Antônio Moraes
Vitória, Espírito Santo, Brazil
Hospital Obras de Caridade Irma Dulce
Salvador, Estado de Bahia, 40.415-006, Brazil
Hospital Santa Izabel
Salvador, Estado de Bahia, 40050-410, Brazil
Hospital Universitario de Brasilia
Brasília, Federal District, Brazil
Hospital Mario Penna
Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital Universitario Joao de Barros Barreto
Belém, Pará, 66073-000, Brazil
Hospital Escola - UFPEL
Pelotas, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-000, 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, São Paulo, 14784-400, Brazil
IAMSPE
São Paulo, São Paulo, Brazil
Related Publications (1)
Basso J, de Lima JB, Bessel M, Tobar Leitao SA, Machado Baptista T, Roithmann S, Franco Carvalhal E, da Silva Schmitt C, Morzoletto Pedrollo I, Schuch A, Atalibio Hartmann A, Neubarth Estivallet CL, Behrend Silva Ribeiro G, Zordan RA, Isaacsson Velho P. The Brazilian national prospective active surveillance (AS) cohort of patients with low-risk prostate cancer in the public health system: vigiaSUS study protocol. BMC Urol. 2023 Dec 11;23(1):208. doi: 10.1186/s12894-023-01380-w.
PMID: 38082337DERIVED
Biospecimen
Paraffin fixed tissue of prostate cancer biopsies
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pedro Henrique Isaacsson Velho, M.D.
Head of Clinical Research
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2022
First Posted
April 25, 2022
Study Start
August 15, 2022
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 18, 2026
Record last verified: 2026-03