Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

NCT01795365 | Terminated

• 1 other identifier: CHUV Active surveillance
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Prostate

Outcome Measures

Primary Outcomes (1)

• Proportion of patients on active surveillance in group Epstein + and Epstein -

  6 years

Secondary Outcomes (6)

• Tumor volume increased, extra-capsular extension or presence of adenopathy assessed on DW-MRI

  baseline, 12, 24, 48 months and every two years.

• BCAR-1 test on biopsies

  baseline, 12, 24 months and every 4 years

• Percentage of patients who discontinued active surveillance by categories (patient's will, clinical or histological criterion)

  Every 6 months for 6 years

• Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups

  10, 15, 20 years

• Percentage of patients who progressed to a metastatic stage at different time points in both groups

  Every year for 6 years

Study Arms (2)

Epstein + (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

Other: Active surveillance

Epstein - (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

Other: Active surveillance

Interventions

Active surveillance OTHER

Epstein + (group I); Epstein - (group II)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy)
• Patients with hypogonadism

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Patrice Jichlinski, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Urology Department, University of Lausanne Hospitals

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: February 20, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2018
• Study Completion: July 26, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Locations

CH (1)