Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

Not Applicable

Terminated

• Conditions: Adenocarcinoma of the Prostate
• Interventions: Other: Active surveillance

• Registration Number: NCT01795365
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-02-18
• Study First Posted: 2013-02-20
• Primary Completion: 2018-07
• Study Completion: 2018-07-26
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epstein - (group II)	Active surveillance	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
Epstein + (group I)	Active surveillance	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

Primary Outcome Measures

Name	Time	Method
Proportion of patients on active surveillance in group Epstein + and Epstein -	6 years

Secondary Outcome Measures

Name	Time	Method
Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups	10, 15, 20 years
BCAR-1 test on biopsies	baseline, 12, 24 months and every 4 years
Percentage of patients who progressed to a metastatic stage at different time points in both groups	Every year for 6 years
Tumor volume increased, extra-capsular extension or presence of adenopathy assessed on DW-MRI	baseline, 12, 24, 48 months and every two years.
Percentage of patients who discontinued active surveillance by categories (patient's will, clinical or histological criterion)	Every 6 months for 6 years
Quality of life assessment	Every 6 months for 6 years	IPSS score/IIEF-5 score( QLQ-C30 + PR25)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois (CHUV); 🇨🇭 Lausanne, Switzerland