Active Surveillance of 2 Groups of Patients With Localize... | NCT01795365

Studies
Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

NCT01795365

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Terminated

Last Update Posted

Sep 28, 2018Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Adenocarcinoma of the Prostate

Interventions

Active surveillance

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Participants are no longer being examined and receiving intervention.

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jul 2018Actual

Completion Date

Jul 26, 2018Actual

First Submitted Date

Jan 23, 2013

First Submission Date that Met QC Criteria

Feb 18, 2013

First Posted Date

Feb 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2018

Last Update Posted Date

Sep 28, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Patrice Jichlinski, Chief of Urology Department, University of Lausanne Hospitals, Centre Hospitalier Universitaire VaudoisPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire VaudoisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Active surveillance	Other		Epstein + (group I) Epstein - (group II)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients on active surveillance in group Epstein + and Epstein -		6 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrice Jichlinski, MD	Centre Hospitalier Universitaire Vaudois	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire Vaudois (CHUV)		Lausanne			Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

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