Health Related Quality of Life and Multidimensional Evaluations of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy

Study Overview
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Brief Summary
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The objective of the study is to compare the evolution over 6 months of Health-Related Quality of Life (HRQOL) among different age groups in subjects with prostate cancer treated with GnRH agonist therapy.

Detailed Description
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Relevant data collected as part of routine medical care will be captured on an electronic Case Report Form (eCRF). Investigator-subject questionnaires and subject self-questionnaires answers will be collected in a paper booklet. This study is non-interventional, thus if some assessments, are not routinely performed by the investigator, he/she will not complete the corresponding sections in the eCRF.

Official Title
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Health Related Quality of Life and Multidimensional Evaluations of a Cohort of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject presenting with histologically confirmed prostate cancer Subject of 60 years and older Subject eligible to start GnRH agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the investigator, prior to the start of the study Subject giving his written consent to participate in the study Subject able to complete questionnaires Exclusion Criteria: Subject simultaneously participating in a clinical trial Subject who previously received a hormonal therapy during the last 6 months before inclusion

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate cancer subjects 60-<70 years<br> | Other: Data collection<br>* Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional assessments or tests will be required.<br>|
| Prostate cancer subjects 70-<75 years<br> | Other: Data collection<br>* Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional assessments or tests will be required.<br>|
| Prostate cancer subjects ≥ 75 years<br> | Other: Data collection<br>* Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional assessments or tests will be required.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) as evaluated by Quality of Life Questionnaire-Elderly 14 items (QLQ-ELD-14) | Evolution overall and in subgroups of age ([60-<70], [70- <75] and ≥ 75 years). | Change from baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRQOL Visual Analog Scale (VAS) score | Subjects evaluate level of satisfaction with their general health status by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. | Baseline and 6 months | 
| Health status scores as evaluated by G8 questionnaire |  | Baseline and 6 months | 
| Overall condition VAS score | Subjects evaluate level of satisfaction with their general health status by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. | Baseline and 6 months | 
| Urinary function scores as evaluated by QOL question of the International Prostate Symptom Score (IPSS) | Subjects will be asked to indicate the score corresponding to their evaluation of their quality of life related to urinary symptoms in response to the following question 'If you were to live the rest of your life with this way of urinating, would you say you would be:' on a scale from 0 (very satisfied) to 6 (very upset). | Baseline and 6 months | 
| Urinary function score VAS | Subjects evaluate level of satisfaction with their urinary function by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. | Baseline and 6 months | 
| Sexual function scores as evaluated by 3 questions on sexual domain of the Urolife Benign Prostatic Hyperplasia-Quality Of Life 9 (BPH-QoL 9) questionnaire |  | Baseline and 6 months | 
| Sexual function VAS score | Subjects evaluate level of satisfaction with their sexual function by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. | Baseline and 6 months | 
| Cognitive status scores as evaluated by Mini Mental State (MMS) |  | Baseline and 6 months | 
| Memory VAS score | Subjects evaluate level of satisfaction with memory (your capacity to remind events or persons you meet) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. | Baseline and 6 months | 
| Mood scores as evaluated by mini Geriatric Depression Scale (GDS) questionnaire | Subjects will be asked four questions and their responses 'Yes' or 'No' will be scored from 0 to 1. | Baseline and 6 months | 
| Mood VAS score | Subjects evaluate level of satisfaction with mood (your feeling of happiness, confidence and serenity) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. | Baseline and 6 months | 
| Motricity scores as evaluated by G8 questionnaire specific domain (3rd item) | Mobility will be scored as follows 'Bed or chair bound' = 0, 'Able to get out of bed/chair but does not go out' = 1, 'Goes out' = 2 | Baseline and 6 months | 
| VAS motricity score | Subjects evaluate level of satisfaction with motricity (your ability to move by yourself in your home or outside) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied' | Baseline and 6 months | 
| Autonomy question | Subjects respond either 'yes' or 'no' to the following autonomy question 'Is the patient living independently at home?' | Baseline and 6 months | 
| Autonomy VAS score | Subjects evaluate level of satisfaction with autonomy (your ability to manage your life alone at home or outside) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'. | Baseline and 6 months |