Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active surveillance This is a multicentric active surveillance prospective cohort study. The eligibility criteria defined are: low-risk prostate adenocarcinoma (clinical stage of cT1-T2a / Group Grade 1 (Gleason score less or equal to 6) / PSA less or equal to 10 ng/ml), transrectal prostate biopsy with at least 12 cores, estimated life expectancy over 10 years, clinical conditions for definitive treatment, multiparametric prostate MRI performed or planned. |
Other: Active surveillance
The active surveillance protocol involves a TRUS prostate biopsy at eligibility and at 12 months. MRI with or without biopsy at eligibility and at 24 months. Clinical evaluation with digital rectal examination and PSA every 6 months. A 12-month 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.
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Outcome Measures
Primary Outcome Measures
- Biopsy pathological reclassification rate [12-month analysis]
Gleason score above 6 (min: 6 - max: 10) in prostate biopsy
Secondary Outcome Measures
- Treatment-Free Survival rate [12-month analysis]
- Overall survival rate [12-month analysis]
- Cancer-Specific Mortality Rate [12-month analysis]
- Metastasis-free survival rate [12-month analysis]
- Quality of life evaluation [12-month analysis]
EQ-5D-5L questionnaire
- Quality of life evaluation [12-month analysis]
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire (min: 0 - max: 60). Higher scores are worse.
- Anxiety evaluation [12-month analysis]
General Anxiety Disorder-7 questionnaire (min: 0 - max: 21) Higher scores are worse
- Biochemical recurrence rate after radical therapy [12-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 Outcome Measures
- Monitoring of active surveillance harm [12-month analysis]
Occurrence of any complications in prostate biopsies
- Evaluation of pathological outcomes in patients undergoing radical prostatectomy [12-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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathological diagnosis of prostate adenocarcinoma;
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Prostate biopsy with at least 12 cores;
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PSA less than or equal to 10 ng/ml and clinical stage cT1/cT2a;
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Gleason score below or equal to 6 (3+3);
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Prostate multi parametric MRI performed or planned
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Availability of pathological samples
Exclusion Criteria:
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Clinical contraindication to prostatectomy and/or radiotherapy procedures;
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Life expectancy below 10 years, according to the Charlson Comorbidity Index (ICC);
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Previous treatment with hormone blockade or radical therapies.
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Intraductal or cribriform histology on biopsy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Moinhos de Vento | Porto Alegre | Rio Grande Do Sul | Brazil | 90035-000 |
Sponsors and Collaborators
- Hospital Moinhos de Vento
Investigators
- Principal Investigator: Pedro Henrique Isaacsson Velho, M.D., Head of Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 56352622.8.1001.5330