NCT05343936

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 490 (estimated)
• Sponsor: Hospital Moinhos de Vento · Academic / Other
• Sex: Male
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-15
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2022-04-25
• Last updated: 2026-03-18

Locations

15 sites across 1 country: Brazil