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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Active surveillance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active surveillance<br>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<br>* The active surveillance protocol involves a TRUS prostate biopsy at eligibility and at 12 months. MRI with or without biopsy at eligibility and at 24 months. Clinical evaluation with digital rectal examination and PSA every 6 months. A 12-month 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.<br>|

What is the study measuring?
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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 analysis | 
| Overall survival rate |  | 12-month analysis | 
| Cancer-Specific Mortality Rate |  | 12-month analysis | 
| Metastasis-free survival rate |  | 12-month analysis | 
| Quality of life evaluation | EQ-5D-5L questionnaire | 12-month analysis | 
| Quality of life evaluation | Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire (min: 0 - max: 60). Higher scores are worse. | 12-month analysis | 
| Anxiety evaluation | General Anxiety Disorder-7 questionnaire (min: 0 - max: 21) Higher scores are worse | 12-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 analysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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active surveillance