Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

Centre Hospitalier Universitaire Vaudois60 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adenocarcinoma of the Prostate

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of patients on active surveillance in group Epstein + and Epstein -

Time frame: 6 years

Secondary Outcomes

Tumor volume increased, extra-capsular extension or presence of adenopathy assessed on DW-MRI

Time frame: baseline, 12, 24, 48 months and every two years.

BCAR-1 test on biopsies

Time frame: baseline, 12, 24 months and every 4 years

Percentage of patients who discontinued active surveillance by categories (patient's will, clinical or histological criterion)

Time frame: Every 6 months for 6 years

Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups

Time frame: 10, 15, 20 years

Percentage of patients who progressed to a metastatic stage at different time points in both groups

Time frame: Every year for 6 years

Quality of life assessment

IPSS score/IIEF-5 score( QLQ-C30 + PR25)