Healthy Population Control Clinical Trial
— PROGEOfficial title:
Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study
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.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | February 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 75 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Clinique Claude BERNARD | Albi | |
| France | CHRU | Besancon | |
| France | Centre François BACLESSE | Caen | Calvados |
| France | CHIC | Castres | |
| France | Hopitaux universitaires de Strasbourg | Strasbourg | Bas-Rhin |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Francois Baclesse |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 10 years after treatment for cancer prostate | No |
| Secondary | Evaluate the anxiety of patients and controls | Evaluate the anxiety of patients and controls | 10 years after treatment for cancer prostate | No |
| Secondary | Assessing depression patients and controls | Assessing depression patients and controls | 10 years after treatments for cancer prostate | No |
| Secondary | Assess the nutritional status of patients and controls | Assess the nutritional status of patients and controls | 10 years after treatments for cancer prostate | No |