Evaluating active surveillance for low-risk prostate cancer in Brazil
Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
This study is testing if closely monitoring Brazilian men with low-risk prostate cancer can safely help them avoid unnecessary treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 490 (estimated) |
| Ages | 18 Years to 78 Years |
| Sex | Male |
| Sponsor | Hospital Moinhos de Vento Academic / other |
| Locations | 15 sites (Salvador, Bahia and 14 other locations) |
| Trial ID | NCT05343936 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a national prospective cohort of Brazilian patients with low-risk prostate cancer who will be monitored through an active surveillance protocol. The approach involves regular assessments, including PSA tests and biopsies, to determine the need for treatment while avoiding immediate radical interventions. The study seeks to validate the effectiveness and safety of active surveillance in the Brazilian population, which has not been previously evaluated. By collecting data on pathological reclassification rates and treatment-free survival, the study will contribute valuable insights into managing prostate cancer in Brazil.
Who should consider this trial
Good fit: Ideal candidates for this study are men diagnosed with low-risk prostate adenocarcinoma, characterized by specific clinical and pathological criteria.
Not a fit: Patients with high-risk prostate cancer or those who have previously undergone treatment for prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated active surveillance strategy for low-risk prostate cancer, potentially reducing unnecessary treatments and improving patient outcomes.
How similar studies have performed: While active surveillance has been successful in various international cohorts, this study is novel as it aims to validate this approach specifically within the diverse Brazilian population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Salvador, Bahia and 14 other locations
- Hospital Obras de Caridade Irma Dulce — Salvador, Bahia, Brazil (Recruiting)
- Hospital Santa Izabel — Salvador, Bahia, Brazil (Recruiting)
- Oncocentro Ceará — Fortaleza, Ceará, Brazil (Recruiting)
- Hospital Universitario de Brasilia — Brasilia, Distrito Federal, Brazil (Recruiting)
- Hospital Universitário Cassiano Antônio Moraes — Vitoria, Espirito Santo, Brazil (Recruiting)
- Hospital Mario Penna — Belo Horizonte, Minas Gerais, Brazil (Recruiting)
- Hospital Erasto Gaertner — Curitiba, Parana, Brazil (Recruiting)
- Hospital Universitario Joao de Barros Barreto — Belem, Para, Brazil (Recruiting)
- Hospital Escola - UFPEL — Pelotas, Rio Grande Do Sul, Brazil (Recruiting)
- Hospital Moinhos de Vento — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
- Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
- Hospital Nossa Senhora da Conceição — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
- Hospital Universidade Dr. Miguel Riet Corrêa Jr. — Rio Grande, Rio Grande Do Sul, Brazil (Recruiting)
- Hospital de Amor — Barretos, Sao Paulo, Brazil (Recruiting)
- Iamspe — São Paulo, Sao Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Pedro Henrique Isaacsson Velho, M.D. — Head of Clinical Research
- Study coordinator: Pedro Henrique Isaacsson Velho, M.D.
- Email: pedro.isaacsson@hmv.org.br
- Phone: +55-51-3314-2965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.