- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01795365
Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lausanne, Switzerland
- Centre Hospitalier Universitaire Vaudois (CHUV)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Epstein + (group I)
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 |
|
Experimental: Epstein - (group II)
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients on active surveillance in group Epstein + and Epstein -
Time Frame: 6 years
|
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
Time Frame: baseline, 12, 24, 48 months and every two years.
|
baseline, 12, 24, 48 months and every two years.
|
|
BCAR-1 test on biopsies
Time Frame: baseline, 12, 24 months and every 4 years
|
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
|
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
|
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
|
Every year for 6 years
|
|
Quality of life assessment
Time Frame: Every 6 months for 6 years
|
IPSS score/IIEF-5 score( QLQ-C30 + PR25)
|
Every 6 months for 6 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patrice Jichlinski, MD, Centre Hospitalier Universitaire Vaudois
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUV Active surveillance
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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