Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
NCT ID: NCT05343936
Last Updated: 2024-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
490 participants
OBSERVATIONAL
2022-08-19
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Active surveillance
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.
Interventions
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Active surveillance
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
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Inclusion Criteria
* 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
* 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
18 Years
78 Years
MALE
No
Sponsors
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Hospital Moinhos de Vento
OTHER
Responsible Party
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Principal Investigators
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Pedro Henrique Isaacsson Velho, M.D.
Role: PRINCIPAL_INVESTIGATOR
Head of Clinical Research
Locations
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Oncocentro Ceará
Fortaleza, Ceará, Brazil
Hospital Universitário Cassiano Antônio Moraes
Vitória, Espírito Santo, Brazil
Hospital Obras de Caridade Irma Dulce
Salvador, Estado de Bahia, Brazil
Hospital Santa Izabel
Salvador, Estado de Bahia, 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, 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, São Paulo, Brazil
IAMSPE
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Karine Martins da Trindade, MD
Role: primary
Vitor Fiorin, MD
Role: primary
Nilo Jorge Leão, MD
Role: primary
Tercia Reis, MD
Role: primary
Role: backup
Eduardo Ribeiro, MD
Role: primary
Renato Corradi, MD
Role: primary
Murilo Luz, MD
Role: primary
Williams Barra, MD
Role: primary
Brasil Silva Neto, MD
Role: primary
Daniel Melecchi de Oliveira Freitas, MD
Role: primary
Hsu Yuan Ting, MD
Role: primary
Joao Paulo Fantin, MD
Role: primary
References
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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.
Other Identifiers
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56352622.8.1001.5330
Identifier Type: -
Identifier Source: org_study_id
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