Adenocarcinoma of the Prostate
Conditions
Brief summary
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
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
Interventions
OTHERActive surveillance
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients on active surveillance in group Epstein + and Epstein - | 6 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Tumor volume increased, extra-capsular extension or presence of adenopathy assessed on DW-MRI | baseline, 12, 24, 48 months and every two 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 | Every 6 months for 6 years | IPSS score/IIEF-5 score( QLQ-C30 + PR25) |
| Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups | 10, 15, 20 years | — |
Countries
Switzerland
Outcome results
None listed