Suspended

Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

What is being tested

Active surveillance

+ Active surveillance

Other

Who is being recruted

From 18 to 75 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: December 2012

See protocol details

Summary

Principal SponsorCentre Hospitalier Universitaire Vaudois

Last updated: September 28, 2018

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01795365

Principal SponsorCentre Hospitalier Universitaire Vaudois

Last updated: September 28, 2018

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

10 inclusion criteria required to participate

Absence of extra-capsular extension

Life expectancy > 10 years

Localized adenocarcinoma of the prostate with a Gleason score of 3+3 (group I patients) or 3+4 (group II patients)

PSA level at diagnosis < 10 ng/ml for group I patients; < 15 ng/ml for group II patients

Show More Criteria

2 exclusion criteria prevent from participating

Patients with hypogonadism

Previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

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

Group II

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, SwitzerlandOpen Centre Hospitalier Universitaire Vaudois (CHUV) in Google Maps

SuspendedOne Study Center