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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active surveillance | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy pathological reclassification rate | Gleason score above 6 (min: 6 - max: 10) in prostate biopsy | 12-month analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Free Survival rate | 12-month and 24-month analysis | |
| Overall survival rate | 12-month and 24-month analysis | |
| Cancer-Specific Mortality Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring of active surveillance harm | Occurrence of any complications in prostate biopsies | 12-month and 24-month analysis |
| Evaluation of pathological outcomes in patients undergoing radical prostatectomy |
Inclusion Criteria:
Exclusion Criteria:
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Brazilian men with prostate adenocarcinoma with localized and low-risk disease. They should be attending in the public healthcare system and being treated by the active surveillance protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Henrique Isaacsson Velho, M.D. | Head of Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncocentro Ceará | Fortaleza | Ceará | 60135-237 | Brazil | ||
| Hospital Universitário Cassiano Antônio Moraes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38082337 | Derived | Basso J, de Lima JB, Bessel M, Tobar Leitao SA, Machado Baptista T, Roithmann S, Franco Carvalhal E, da Silva Schmitt C, Morzoletto Pedrollo I, Schuch A, Atalibio Hartmann A, Neubarth Estivallet CL, Behrend Silva Ribeiro G, Zordan RA, Isaacsson Velho P. The Brazilian national prospective active surveillance (AS) cohort of patients with low-risk prostate cancer in the public health system: vigiaSUS study protocol. BMC Urol. 2023 Dec 11;23(1):208. doi: 10.1186/s12894-023-01380-w. |
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Paraffin fixed tissue of prostate cancer biopsies
|
| 12-month and 24-month analysis |
| Metastasis-free survival rate | 12-month and 24-month analysis |
| Quality of life evaluation | EQ-5D-5L questionnaire | 12-month and 24-month analysis |
| EPIC evaluation | Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire (min: 0 - max: 60). Higher scores are worse. | 12-month and 24-month analysis |
| Anxiety evaluation | General Anxiety Disorder-7 questionnaire (min: 0 - max: 21) Higher scores are worse | 12-month and 24-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 and 24-month analysis |
Presence or absence of any of the following criteria: Gleason score above 6 (min: 6 - max: 10), positive surgical margins, extracapsular extension, seminal vesicle invasion or positive lymph node metastases
| 12-month and 24-month analysis |
| Vitória |
| Espírito Santo |
| Brazil |
| Hospital Obras de Caridade Irma Dulce | Salvador | Estado de Bahia | 40.415-006 | Brazil |
| Hospital Santa Izabel | Salvador | Estado de Bahia | 40050-410 | Brazil |
| Hospital Universitario de Brasilia | Brasília | Federal District | Brazil |
| Hospital Mario Penna | Belo Horizonte | Minas Gerais | Brazil |
| Hospital Erasto Gaertner | Curitiba | Paraná | Brazil |
| Hospital Universitario Joao de Barros Barreto | Belém | Pará | 66073-000 | Brazil |
| Hospital Escola - UFPEL | Pelotas | Rio Grande do Sul | Brazil |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90035-000 | Brazil |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital Nossa Senhora da Conceição | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital Universidade Dr. Miguel Riet Corrêa Jr. | Rio Grande | Rio Grande do Sul | Brazil |
| Hospital de Amor | Barretos | São Paulo | 14784-400 | Brazil |
| IAMSPE | São Paulo | São Paulo | Brazil |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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