Prostate Cancer
Conditions
Keywords
active surveillance
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.
Interventions
OTHERActive 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.
Sponsors
Hospital Moinhos de Vento
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 78 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biopsy pathological reclassification rate | 12-month analysis | Gleason score above 6 (min: 6 - max: 10) in prostate biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metastasis-free survival rate | 12-month and 24-month analysis | — |
| Quality of life evaluation | 12-month and 24-month analysis | EQ-5D-5L questionnaire |
| Treatment-Free Survival rate | 12-month and 24-month analysis | — |
| Overall survival rate | 12-month and 24-month analysis | — |
| 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. |
| Anxiety evaluation | 12-month and 24-month analysis | General Anxiety Disorder-7 questionnaire (min: 0 - max: 21) Higher scores are worse |
| Cancer-Specific Mortality Rate | 12-month and 24-month analysis | — |
| 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; |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORPedro Henrique Isaacsson Velho, M.D.
Head of Clinical Research
Outcome results
None listed