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The Brazilian National Prospective Active Surveillance (AS) Cohort of Patients with Low-Risk Prostate Cancer in the Public Health System: vigiaSUS Study Protocol - Beyond the Abstract

Active surveillance is the preferred strategy for low-risk patients to avoid or delay definitive treatment. Results in cohorts of patients on AS demonstrated that this strategy is safe in low-risk patients and is considered standard of care by the main guidelines.1-6


Concerns remain regarding its applicability in certain patient subgroups, such as black men, who are known to have worse prostate cancer outcomes and were also notably underrepresented, comprising less than 10% of patients, in the AS cohorts.7-10 Additionally, these men often have less access to treatments, which can lead to disparities in outcomes.11 In Brazil, the population is wonderfully diverse, representing a mix of various racial backgrounds. It's worth noting that 56.1% of individuals self-identify as non-white.12

The VigiaSUS study is a significant and pioneering effort aiming to assess the feasibility and outcomes of AS in a diverse population, particularly in the context of low-risk prostate cancer.

The study, developed by Hospital Moinhos de Vento through the Institutional Development Program of the Brazilian National Health System (PROADI-SUS) in partnership with the Ministry of Health, is being conducted in more than 20 centers distributed across the five regions of Brazil. The study is divided into three major axes: prospective, which aims to evaluate and collect data from a cohort of patients in AS; retrospective, which evaluates the budget impact of AS on the national health system; and the analysis of urologists' perception to AS in the public health system.

In this prospective cohort study, patients are included based on an initial diagnosis of low-risk prostate cancer up to 12 months prior to entry into the study. Patient follow-up is based on a pre-established AS protocol with a biopsy at 12 months and then every 2 years, along with an initial multiparametric MRI and then every 2 years. All biopsies and images are reviewed by two specialized pathologists and radiologists in genitourinary tumors, respectively.

Recruitment began at the end of 2022, enrolling 200 patients so far, of whom 116 are still under AS. At this point, the cohort comprises 45% of non-white men, and as the study is expanding to the north and northeast regions of Brazil, these numbers may increase. The rate of pathological reclassification during the initial biopsy review is 29%. In addition, The study is assessing the expression of PTEN by immunohistochemistry in biopsies to investigate the role of this marker in AS, and collecting data regarding the quality of life and anxiety data through validated questionnaires.

To the best of our knowledge, this is one of the largest AS study cohorts with a majority of non-white patients, and the first being conducted in South America. Our data are still preliminary, and as the study progresses, we are confident that we will provide relevant data on AS in the Brazilian population in the coming years.

Written by: Jeziel Basso,1 Ricardo Andre Zordan,2 Pedro Isaacsson Velho1,3

  1. Oncology Department, Hospital Moinhos de Vento, Porto Alegre, Rio Grande do Sul, Brazil.
  2. Urology Department, Hospital Moinhos de Vento, Porto Alegre, Rio Grande do Sul, Brazil.
  3. Oncology Department, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, USA.
References:

  1. Klotz L, Vesprini D, Sethukavalan P, Jethava V, Zhang L, Jain S, et al. Long-term follow-up of a large active surveillance cohort of patients with Prostate cancer. J Clin Oncol. 2015;33:272–7.
  2. Godtman RA, Holmberg E, Khatami A, Pihl CG, Stranne J, Hugosson J. Long term results of active surveillance in the göteborg randomized, population based Prostate cancer screening trial. Eur Urol. 2016;70:760–6
  3. Welty CJ, Cowan JE, Nguyen H, Shinohara K, Perez N, Greene KL, et al. Extended followup and risk factors for Disease reclassification in a large active surveillance cohort for localized Prostate cancer. J Urol. 2015;193:807–11.
  4. Selvadurai ED, Singhera M, Thomas K, Mohammed K, Woode-Amissah R, Horwich A, et al. Medium-term outcomes of active surveillance for localised Prostate cancer. Eur Urol. 2013;64:981–7.
  5. Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, et al. EAU-ESTRO-SIOG guidelines on Prostate cancer. Part 1: screening, diagnosis, and local treatment with curative intent. Eur Urol. 2017;71:618–29.
  6. Sanda MG, Cadeddu JA, Kirkby E, Chen RC, Crispino T, Fontanarosa J, et al. Clinically localized Prostate cancer: AUA/ASTRO/SUO guideline. Part II: recommended approaches and details of specific care options. J Urol.2018;199:990–7
  7. Chornokur G, Dalton K, Borysova ME, Kumar NB. Disparities at presentation, diagnosis, treatment, and survival in African American men, affected by Prostate cancer. Prostate. 2011;71:985–97
  8. Sundi, D. et al. African American Men With Very Low–Risk Prostate Cancer Exhibit Adverse Oncologic Outcomes After Radical Prostatectomy: Should Active Surveillance Still Be an Option for Them?J Clin Oncol 31:2991-2997. © 2013 by American Society of Clinical Oncology
  9. Iremashvili, V. Clinical and Demographic Characteristics Associated With Prostate Cancer Progression in Patients on Active Surveillance. The Journal of Urology. Vol. 187, 1594-1600, May 2012.
  10. Faisal, F. et al. African American race is not associated with risk of reclassification during active surveillance: Results from the Canary Prostate Cancer Active Surveillance Study (PASS). Journal of Urology, 203(4), 727-733.
  11. Moses KA, Paciorek AT, Penson DF, Carroll PR, Master VA. Impact of ethnicity on primary treatment choice and mortality in men with Prostate cancer: data from capsure. J Clin Oncol. 2010;28:1069–74.
  12. Instituto Nacional de Câncer (INCA). Title of subordinate document in: Estimativa 2020: incidência de câncer no Brasil. Rio de janeiro: INCA. 2020.
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