Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study (PROGE)

March 3, 2015 updated by: Centre Francois Baclesse

This is a multicenter pilot study, proposed for cases and controls 3 departments in France.

Cases are cured patients who have had prostate cancer for at least 10 years. Cookies are healthy subjects selected by lottery on voter list.

Volunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Volunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.

During this consultation, ADL, IADL and MMS questionnary will be completed. neurocognitif testing will be done.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albi, France, 81000
        • Clinique Claude Bernard
      • Besancon, France, 25000
        • CHRU
      • Castres, France, 81 000
        • CHIC
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67000
        • Hopitaux Universitaires de Strasbourg
    • Calvados
      • Caen, Calvados, France, 14076
        • Centre Francois Baclesse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria for patients:

  • Patients aged 75 years or more
  • Patients with a personal history of prostate cancer with a diagnosis ≥ 10 years
  • Patients who received curative treatment (surgery, radiotherapy,hormone therapy, brachytherapy, technical ablative) for localized prostate cancer
  • Patients considered cured of prostate cancer (regardless of initial treatment)
  • Patients with previously agreed to participate in a case-control study in the general population (study QALIPRO) as a case and volunteer to receive an assessment of geriatric
  • Signature of consent
  • Affiliation to a social security system

Exclusion Criteria for patients:

  • Patients under 75 years
  • Patients with recurrent or metastatic
  • Persons deprived of liberty or under guardianship

Inclusion Criteria for control population:

  • Male subjects
  • Subjects of 75 years or more
  • Subjects that do not have cancer or a history of cancer (except basal cell skin cancer)
  • Subject has previously agreed to participate in a case-control study in the general population (study QALIPRO) as a voluntary witness and to benefit from a balance oncogeriatrics
  • Subjects who gave their written consent to participate in the study

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: geriatric assessment
Other: geriatric assessment
A single geriatric assessment with a geriatrician was proposed to patients and to control population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact of treatments
Time Frame: 10 years after treatment for cancer prostate
The main objective of this study is to evaluate the impact of treatments and their effects on the autonomy of patients over 75 years have been treated and cured for prostate cancer.
10 years after treatment for cancer prostate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the anxiety of patients and controls
Time Frame: 10 years after treatment for cancer prostate
Evaluate the anxiety of patients and controls
10 years after treatment for cancer prostate
Assessing depression patients and controls
Time Frame: 10 years after treatments for cancer prostate
Assessing depression patients and controls
10 years after treatments for cancer prostate
Assess the nutritional status of patients and controls
Time Frame: 10 years after treatments for cancer prostate
Assess the nutritional status of patients and controls
10 years after treatments for cancer prostate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 22, 2013

Study Record Updates

Last Update Posted (Estimate)

March 4, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROGE
  • 2011-A01256-35 (Other Identifier: ID-RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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