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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Data collection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 831

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Ipsen Central Contact

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Prostate Cancer subjects aged ≥ 60

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: A-FR-52014-228

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No