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

Recruiting

• Conditions: Prostate Cancer
• Interventions: Other: Active surveillance

• Registration Number: NCT05343936
• Lead Sponsor: Hospital Moinhos de Vento

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.

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 Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Study Start: 2022-08-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18
• Primary Completion: 2026-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 490

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active surveillance	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.

Primary Outcome Measures

Name	Time	Method
Biopsy pathological reclassification rate	12-month analysis	Gleason score above 6 (min: 6 - max: 10) in prostate biopsy

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Oncocentro Ceará; 🇧🇷 Fortaleza, Ceará, Brazil

Hospital Universitario Joao de Barros Barreto; 🇧🇷 Belem, Para, Brazil

Hospital Santa Izabel; 🇧🇷 Salvador, Bahia, Brazil

Hospital Mario Penna; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Hospital Nossa Senhora da Conceição; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Escola - UFPEL; 🇧🇷 Pelotas, Rio Grande Do Sul, Brazil

Hospital Universitário Cassiano Antônio Moraes; 🇧🇷 Vitoria, Espirito Santo, Brazil

Hospital Universitario de Brasilia; 🇧🇷 Brasilia, Distrito Federal, Brazil

IAMSPE; 🇧🇷 São Paulo, Sao Paulo, Brazil

Hospital Obras de Caridade Irma Dulce; 🇧🇷 Salvador, Bahia, Brazil

Hospital Universidade Dr. Miguel Riet Corrêa Jr.; 🇧🇷 Rio Grande, Rio Grande Do Sul, Brazil

Hospital Erasto Gaertner; 🇧🇷 Curitiba, Parana, Brazil

Hospital de Amor; 🇧🇷 Barretos, Sao Paulo, 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