Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Active surveillance

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.

• Study Type: Observational
• Enrollment (Estimated): 490

Contacts and Locations

Study Locations

• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60135-237
      • Oncocentro Ceará
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil
      • Hospital Universitário Cassiano Antonio Moraes
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40050-410
      • Hospital Santa Izabel
    • Salvador, Estado de Bahia, Brazil, 40.415-006
      • Hospital Obras de Caridade Irma Dulce
  • Federal District
    • Brasília, Federal District, Brazil
      • Hospital Universitario de Brasilia
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Hospital Mario Penna
  • Paraná
    • Curitiba, Paraná, Brazil
      • Hospital Erasto Gaertner
  • Pará
    • Belém, Pará, Brazil, 66073-000
      • Hospital Universitário João de Barros Barreto
  • Rio Grande do Sul
    • Pelotas, Rio Grande do Sul, Brazil
      • Hospital Escola - UFPEL
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Hospital Nossa Senhora da Conceição
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
      • Hospital Moinhos de Vento
    • Rio Grande, Rio Grande do Sul, Brazil
      • Hospital Universidade Dr. Miguel Riet Corrêa Jr.
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Hospital de Amor
    • São Paulo, São Paulo, Brazil
      • IAMSPE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biopsy pathological reclassification rate	Gleason score above 6 (min: 6 - max: 10) in prostate biopsy	12-month analysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	EQ-5D-5L questionnaire	12-month and 24-month analysis
EPIC evaluation	Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire (min: 0 - max: 60). Higher scores are worse.	12-month and 24-month analysis
Anxiety evaluation	General Anxiety Disorder-7 questionnaire (min: 0 - max: 21) Higher scores are worse	12-month and 24-month analysis
Biochemical recurrence rate after radical therapy	PSA greater than or equal to 0.2 ng/ml after radical prostatectomy or PSA nadir plus 2 ng/ml after radiotherapy;	12-month and 24-month analysis

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring of active surveillance harm	Occurrence of any complications in prostate biopsies	12-month and 24-month analysis
Evaluation of pathological outcomes in patients undergoing radical prostatectomy	Presence or absence of any of the following criteria: Gleason score above 6 (min: 6 - max: 10), positive surgical margins, extracapsular extension, seminal vesicle invasion or positive lymph node metastases	12-month and 24-month analysis

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento
• Investigators: Principal Investigator: Pedro Henrique Isaacsson Velho, M.D., Head of Clinical Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: active surveillance
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: 56352622.8.1001.5330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No