Prostate CancerNCT05343936
Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
An observational study of Prostate Cancer, run by Hospital Moinhos de Vento at 15 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Active surveillance
- How many people
- 490 participants
- Where
- 15 sitesBrazil
- Study dates
- 15 Aug 2022to Dec 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Brazil15 sites
Hospital de Amor
Barretos, São Paulo, 14784-400
Hospital Universitario Joao de Barros Barreto
Belém, Pará, 66073-000
Hospital Mario Penna
Belo Horizonte, Minas Gerais
Hospital Universitario de Brasilia
Brasília, Federal District
Hospital Erasto Gaertner
Curitiba, Paraná
Oncocentro Ceará
Fortaleza, Ceará, 60135-237
Hospital Escola - UFPEL
Pelotas, Rio Grande do Sul
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-000
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul
Hospital Universidade Dr. Miguel Riet Corrêa Jr.
Rio Grande, Rio Grande do Sul
Hospital Obras de Caridade Irma Dulce
Salvador, Estado de Bahia, 40.415-006
Hospital Santa Izabel
Salvador, Estado de Bahia, 40050-410
IAMSPE
São Paulo, São Paulo
Hospital Universitário Cassiano Antônio Moraes
Vitória, Espírito Santo
About this study
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.
Read the 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
- Being tested
- Active surveillance
- Keywords
- active surveillance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active surveillanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy pathological reclassification rate
Gleason score above 6 (min: 6 - max: 10) in prostate biopsy
Measured: 12-month analysis
Secondary outcomes (8)
Treatment-Free Survival rate
Measured: 12-month and 24-month analysis
Overall survival rate
Measured: 12-month and 24-month analysis
Cancer-Specific Mortality Rate
Measured: 12-month and 24-month analysis
Metastasis-free survival rate
Measured: 12-month and 24-month analysis
Quality of life evaluation
EQ-5D-5L questionnaire
Measured: 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.
Measured: 12-month and 24-month analysis
Anxiety evaluation
General Anxiety Disorder-7 questionnaire (min: 0 - max: 21) Higher scores are worse
Measured: 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;
Measured: 12-month and 24-month analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start15 Aug 2022
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 490 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Henrique Isaacsson Velho, M.D., Principal investigator, Head of Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343936
- Sponsor's protocol ID
- 56352622.8.1001.5330
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38082337
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
- ClinicalTrials.gov ID
- NCT05343936
- Acronym / sponsor ID
- 56352622.8.1001.5330
- Conditions
- Prostate Cancer
- Keywords
- active surveillance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active surveillance | – | Other: Active surveillanceThis 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. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active surveillanceThe 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. | Other | Active surveillance |
Primary outcome
Biopsy pathological reclassification rate
Time frame: 12-month analysis
Gleason score above 6 (min: 6 - max: 10) in prostate biopsy
8 secondary outcomes
Treatment-Free Survival rate
Time frame: 12-month and 24-month analysis
Overall survival rate
Time frame: 12-month and 24-month analysis
Cancer-Specific Mortality Rate
Time frame: 12-month and 24-month analysis
Metastasis-free survival rate
Time frame: 12-month and 24-month analysis
Quality of life evaluation
Time frame: 12-month and 24-month analysis
EPIC evaluation
Time frame: 12-month and 24-month analysis
Anxiety evaluation
Time frame: 12-month and 24-month analysis
Biochemical recurrence rate after radical therapy
Time frame: 12-month and 24-month analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 38082337Basso 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Henrique Isaacsson Velho, M.D. principal investigator
Head of Clinical Research
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Hospital Moinhos de Vento at 15 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy pathological reclassification rate (time frame: 12-month analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05343936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.