Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

NCT ID: NCT01795365

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2018-07-26

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

Conditions

Adenocarcinoma of the Prostate

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Active surveillance

Intervention Type: OTHER

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

Group Type: EXPERIMENTAL

Active surveillance

Intervention Type: OTHER

Interventions

Active surveillance

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Prof. Patrice Jichlinski

Chief of Urology Department, University of Lausanne Hospitals

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrice Jichlinski, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

CHUV Active surveillance

Identifier Type: -

Identifier Source: org_study_id