Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

Study Overview
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Brief Summary
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Active Surveillance manages selected men with prostate cancer expectantly with curative intent. This means men are carefully selected and subsequently actively observed in order to have the possibility to offer them curative treatment once the tumor seems to progress. The goal of this study is to validate the treatment option Active Surveillance in men with localized, well differentiated prostate cancer, in order to limit the amount of overtreatment. A number of key points will be studied, such as the pathological findings in radical prostatectomy specimens, and the effect of expectancy on the quality of life.

Detailed Description
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Objectives: Primary - To evaluate the equivalence of the time on active surveillance before an active treatment between group Epstein + and the expanded active surveillance group (Epstein -) Secondary To evaluate the role of diffusion-weighted MRI (DW-MRI) in the initial diagnosis and the follow-up of patients under active surveillance To evaluate the role of BCAR-1 to predict the clinical outcome of localized prostate cancer To evaluate the proportion of patients who discontinued active surveillance To evaluate the mortality at 10, 15 and 20 years from the inclusion in the study To evaluate the time to radical treatment To evaluate the time to metastatic disease To evaluate patients quality of life

Conditions
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Adenocarcinoma of the Prostate

Intervention / Treatment
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* Other: Active surveillance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Localized adenocarcinoma of the prostate with a Gleason score of 3+3 (group I patients) or 3+4 (group II patients) Percentage of tumor biopsy invasion <50% and/or with a size of maximum 8 mm With a number of positive tumor biopsies ≤3 (group I patients) or ≤ 5 (group II patients) TNM stage T1-2a N0 M0 (group I patients); TNM stage T1-2c N0 M0 (group II patients) PSA level at diagnosis < 10 ng/ml for group I patients; < 15 ng/ml for group II patients Tumor volume negative (group I patients); positive (group II patients) Absence of extra-capsular extension Life expectancy > 10 years Signed informed consent Patient has elected active surveillance as preferred management plan for the prostate cancer Exclusion Criteria: Previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy) Patients with hypogonadism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epstein + (group I)<br>Epstein + (Group I) PSA <10 ng/ml; Gleason 3+3=6; Number of positive biopsies ≤3/12; % of tumor biopsy invasion <50% or ≤3mm; mp MRI negative; c-rTNM T1-T2a N0 M0 | Other: Active surveillance<br> <br> |
| Experimental: Epstein - (group II)<br>Epstein - (Group II) PSA <15 ng/ml; Gleason score max 3+4; Number of positive biopsies ≤5/12 % of tumor biopsy invasion <50% and ≤8mm; mp MRI positive; T1-T2c N0 M0 | Other: Active surveillance<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on active surveillance in group Epstein + and Epstein - |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor volume increased, extra-capsular extension or presence of adenopathy assessed on DW-MRI |  | baseline, 12, 24, 48 months and every two years. | 
| BCAR-1 test on biopsies |  | baseline, 12, 24 months and every 4 years | 
| Percentage of patients who discontinued active surveillance by categories (patient's will, clinical or histological criterion) |  | Every 6 months for 6 years | 
| Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups |  | 10, 15, 20 years | 
| Percentage of patients who progressed to a metastatic stage at different time points in both groups |  | Every year for 6 years | 
| Quality of life assessment | IPSS score/IIEF-5 score( QLQ-C30 + PR25) | Every 6 months for 6 years |