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NCT Number: NCT05343936

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–78 year

Sex eligibility

Male

Study type

Observational

Primary location

Oncocentro Ceará, Fortaleza, Ceará, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Surveillance

Other

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.

Primary outcomes

  1. Biopsy pathological reclassification rate

    Time frame: 12-month analysis

    Gleason score above 6 (min: 6 - max: 10) in prostate biopsy

Secondary outcomes

  1. Treatment-Free Survival rate

    Time frame: 12-month and 24-month analysis

  2. Overall survival rate

    Time frame: 12-month and 24-month analysis

  3. Cancer-Specific Mortality Rate

    Time frame: 12-month and 24-month analysis

  4. Metastasis-free survival rate

    Time frame: 12-month and 24-month analysis

  5. Quality of life evaluation

    Time frame: 12-month and 24-month analysis

    EQ-5D-5L questionnaire

  6. EPIC evaluation

    Time frame: 12-month and 24-month analysis

    Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire (min: 0 - max: 60). Higher scores are worse.

  7. Anxiety evaluation

    Time frame: 12-month and 24-month analysis

    General Anxiety Disorder-7 questionnaire (min: 0 - max: 21) Higher scores are worse

  8. Biochemical recurrence rate after radical therapy

    Time frame: 12-month and 24-month analysis

    PSA greater than or equal to 0.2 ng/ml after radical prostatectomy or PSA nadir plus 2 ng/ml after radiotherapy;

Other outcomes

  1. Monitoring of active surveillance harm

    Time frame: 12-month and 24-month analysis

    Occurrence of any complications in prostate biopsies

  2. Evaluation of pathological outcomes in patients undergoing radical prostatectomy

    Time frame: 12-month and 24-month analysis

    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

Sponsors and collaborators

Lead sponsor

Hospital Moinhos de Vento

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2022
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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