Back to resultsActive Surveillance of 2 Groups of Patients With Localized Prostate Cancer
Primary Purpose
Adenocarcinoma of the Prostate
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Active surveillance
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Prostate
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
Sites / Locations
- Centre Hospitalier Universitaire Vaudois (CHUV)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Epstein + (group I)
Epstein - (group II)
Arm Description
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
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
Outcomes
Primary Outcome Measures
Proportion of patients on active surveillance in group Epstein + and Epstein -
Secondary Outcome Measures
Tumor volume increased, extra-capsular extension or presence of adenopathy assessed on DW-MRI
BCAR-1 test on biopsies
Percentage of patients who discontinued active surveillance by categories (patient's will, clinical or histological criterion)
Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups
Percentage of patients who progressed to a metastatic stage at different time points in both groups
Quality of life assessment
IPSS score/IIEF-5 score( QLQ-C30 + PR25)
Full Information
NCT ID
NCT01795365
First Posted
January 23, 2013
Last Updated
September 25, 2018
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT01795365
Brief Title
Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Participants are no longer being examined and receiving intervention.
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epstein + (group I)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Epstein - (group II)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Active surveillance
Primary Outcome Measure Information:
Title
Proportion of patients on active surveillance in group Epstein + and Epstein -
Time Frame
6 years
Secondary Outcome Measure Information:
Title
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.
Title
BCAR-1 test on biopsies
Time Frame
baseline, 12, 24 months and every 4 years
Title
Percentage of patients who discontinued active surveillance by categories (patient's will, clinical or histological criterion)
Time Frame
Every 6 months for 6 years
Title
Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups
Time Frame
10, 15, 20 years
Title
Percentage of patients who progressed to a metastatic stage at different time points in both groups
Time Frame
Every year for 6 years
Title
Quality of life assessment
Description
IPSS score/IIEF-5 score( QLQ-C30 + PR25)
Time Frame
Every 6 months for 6 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Jichlinski, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer
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