Clinical trial NCT05343936: Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
Official title: Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: active surveillance
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 490
Sex: MALE
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility 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

Primary outcomes:
measure: Biopsy pathological reclassification rate
timeFrame: 12-month analysis
Secondary outcomes:
measure: Treatment-Free Survival rate
timeFrame: 12-month and 24-month analysis
measure: Overall survival rate
timeFrame: 12-month and 24-month analysis
measure: Cancer-Specific Mortality Rate
timeFrame: 12-month and 24-month analysis
measure: Metastasis-free survival rate
timeFrame: 12-month and 24-month analysis
measure: Quality of life evaluation
timeFrame: 12-month and 24-month analysis
measure: EPIC evaluation
timeFrame: 12-month and 24-month analysis
measure: Anxiety evaluation
timeFrame: 12-month and 24-month analysis
measure: Biochemical recurrence rate after radical therapy
timeFrame: 12-month and 24-month analysis
Other outcomes:
measure: Monitoring of active surveillance harm
timeFrame: 12-month and 24-month analysis
measure: Evaluation of pathological outcomes in patients undergoing radical prostatectomy
timeFrame: 12-month and 24-month analysis
Locations:
city: Salvador
country: Brazil
facility: Hospital Obras de Caridade Irma Dulce
state: Bahia
city: Salvador
country: Brazil
facility: Hospital Santa Izabel
state: Bahia
city: Fortaleza
country: Brazil
facility: Oncocentro Ceará
state: Ceará
city: Brasilia
country: Brazil
facility: Hospital Universitario de Brasilia
state: Distrito Federal
city: Vitoria
country: Brazil
facility: Hospital Universitário Cassiano Antônio Moraes
state: Espirito Santo
city: Belo Horizonte
country: Brazil
facility: Hospital Mario Penna
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Parana
city: Belem
country: Brazil
facility: Hospital Universitario Joao de Barros Barreto
state: Para
city: Pelotas
country: Brazil
facility: Hospital Escola - UFPEL
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição
state: Rio Grande Do Sul
city: Rio Grande
country: Brazil
facility: Hospital Universidade Dr. Miguel Riet Corrêa Jr.
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital de Amor
state: Sao Paulo
city: São Paulo
country: Brazil
facility: IAMSPE
state: Sao Paulo
Study officials:
affiliation: Head of Clinical Research
name: Pedro Henrique Isaacsson Velho, M.D.
role: PRINCIPAL_INVESTIGATOR
References: