Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study (PROGE)
Primary Purpose
Prostate Cancer Cured, Healthy Population Control
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
geriatric assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer Cured focused on measuring prostate cancer cured, aged patients
Eligibility Criteria
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
Sites / Locations
- Hopitaux universitaires de Strasbourg
- Centre François BACLESSE
- Clinique Claude BERNARD
- CHRU
- CHIC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
geriatric assessment
Arm Description
geriatric assessment
Outcomes
Primary Outcome Measures
impact of treatments
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.
Secondary Outcome Measures
Evaluate the anxiety of patients and controls
Evaluate the anxiety of patients and controls
Assessing depression patients and controls
Assessing depression patients and controls
Assess the nutritional status of patients and controls
Assess the nutritional status of patients and controls
Full Information
NCT ID
NCT01797692
First Posted
February 5, 2013
Last Updated
March 3, 2015
Sponsor
Centre Francois Baclesse
1. Study Identification
Unique Protocol Identification Number
NCT01797692
Brief Title
Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study
Acronym
PROGE
Official Title
Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Cured, Healthy Population Control
Keywords
prostate cancer cured, aged patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
geriatric assessment
Arm Type
Other
Arm Description
geriatric assessment
Intervention Type
Other
Intervention Name(s)
geriatric assessment
Intervention Description
A single geriatric assessment with a geriatrician was proposed to patients and to control population.
Primary Outcome Measure Information:
Title
impact of treatments
Description
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.
Time Frame
10 years after treatment for cancer prostate
Secondary Outcome Measure Information:
Title
Evaluate the anxiety of patients and controls
Description
Evaluate the anxiety of patients and controls
Time Frame
10 years after treatment for cancer prostate
Title
Assessing depression patients and controls
Description
Assessing depression patients and controls
Time Frame
10 years after treatments for cancer prostate
Title
Assess the nutritional status of patients and controls
Description
Assess the nutritional status of patients and controls
Time Frame
10 years after treatments for cancer prostate
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hopitaux universitaires de Strasbourg
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67000
Country
France
Facility Name
Centre François BACLESSE
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
Clinique Claude BERNARD
City
Albi
ZIP/Postal Code
81000
Country
France
Facility Name
CHRU
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
CHIC
City
Castres
ZIP/Postal Code
81 000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study
We'll reach out to this number within 24 hrs