Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

September 25, 2018 updated by: Prof. Patrice Jichlinski, Centre Hospitalier Universitaire Vaudois

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

Terminated

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois (CHUV)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patrice Jichlinski, MD, Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 26, 2018

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

February 18, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

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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