Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Brazil / NCT05343936
Active, not recruiting Observational

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

NCT05343936 · tracked via the Priya Life Science Brazil tracker
Sponsor
Hospital Moinhos de Vento
Phase
Observational
Started
2022-08-15
Last updated
2026-03-18

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Active surveillance

Active 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.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Oncocentro Ceará Fortaleza Ceará
Hospital Universitário Cassiano Antônio Moraes Vitória Espírito Santo
Hospital Obras de Caridade Irma Dulce Salvador Estado de Bahia
Hospital Santa Izabel Salvador Estado de Bahia
Hospital Universitario de Brasilia Brasília Federal District
Hospital Mario Penna Belo Horizonte Minas Gerais
Hospital Erasto Gaertner Curitiba Paraná
Hospital Universitario Joao de Barros Barreto Belém Pará
Hospital Escola - UFPEL Pelotas Rio Grande do Sul
Hospital Moinhos de Vento Porto Alegre Rio Grande do Sul
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 de Amor Barretos São Paulo
IAMSPE São Paulo São Paulo

More Hospital Moinhos de Vento trials in Brazil

Neuromuscular Electrical Stimulation in a Patient on Invasive Mechanical Ventilation (MOVCARE) Recruiting
Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Ischemic Stroke Recruiting
Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System Active, not recruiting
Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE) Recruiting
Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT Recruiting

Other trials for the same condition

A Study for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients Active, not recruiting
Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy Recruiting
Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer After Androgen Deprivation Therapy Recruiting
Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC) Active, not recruiting
Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05343936 on ClinicalTrials.gov ↗ ← All trials in Brazil