Clinical trial NCT01795365: Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adenocarcinoma of the Prostate
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients on active surveillance in group Epstein + and Epstein -
timeFrame: 6 years
Secondary outcomes:
measure: Tumor volume increased, extra-capsular extension or presence of adenopathy assessed on DW-MRI
timeFrame: baseline, 12, 24, 48 months and every two years.
measure: BCAR-1 test on biopsies
timeFrame: baseline, 12, 24 months and every 4 years
measure: Percentage of patients who discontinued active surveillance by categories (patient's will, clinical or histological criterion)
timeFrame: Every 6 months for 6 years
measure: Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups
timeFrame: 10, 15, 20 years
measure: Percentage of patients who progressed to a metastatic stage at different time points in both groups
timeFrame: Every year for 6 years
measure: Quality of life assessment
timeFrame: Every 6 months for 6 years
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Patrice Jichlinski, MD
role: PRINCIPAL_INVESTIGATOR
References: