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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05343936
• Other study ID #: 56352622.8.1001.5330
• Status: Recruiting
• Start date: August 19, 2022
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Hospital Moinhos de Vento
• Contact: Pedro Henrique Isaacsson Velho, M.D.
• Phone: +55-51-3314-2965
• Email: pedro.isaacsson[@]hmv.org.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. This cohort aim to evaluate and validate the active surveillance strategy in Brazil.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: December 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Amor	Barretos	Sao Paulo
Brazil	Hospital Universitario Joao de Barros Barreto	Belem	Para
Brazil	Hospital Mario Penna	Belo Horizonte	Minas Gerais
Brazil	Hospital Universitario de Brasilia	Brasilia	Distrito Federal
Brazil	Hospital Erasto Gaertner	Curitiba	Parana
Brazil	Oncocentro Ceará	Fortaleza	Ceará
Brazil	Hospital Escola - UFPEL	Pelotas	Rio Grande Do Sul
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Moinhos de Vento	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 Obras de Caridade Irma Dulce	Salvador	Bahia
Brazil	Hospital Santa Izabel	Salvador	Bahia
Brazil	IAMSPE	São Paulo	Sao Paulo
Brazil	Hospital Universitário Cassiano Antônio Moraes	Vitoria	Espirito Santo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Monitoring of active surveillance harm	Occurrence of any complications in prostate biopsies	12-month and 24-month analysis
Other	Evaluation of pathological outcomes in patients undergoing radical prostatectomy	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
Primary	Biopsy pathological reclassification rate	Gleason score above 6 (min: 6 - max: 10) in prostate biopsy	12-month analysis
Secondary	Treatment-Free Survival rate		12-month and 24-month analysis
Secondary	Overall survival rate		12-month and 24-month analysis
Secondary	Cancer-Specific Mortality Rate		12-month and 24-month analysis
Secondary	Metastasis-free survival rate		12-month and 24-month analysis
Secondary	Quality of life evaluation	EQ-5D-5L questionnaire	12-month and 24-month analysis
Secondary	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
Secondary	Anxiety evaluation	General Anxiety Disorder-7 questionnaire (min: 0 - max: 21) Higher scores are worse	12-month and 24-month analysis
Secondary	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