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

Prostate Cancer Clinical Trial

— PRISME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516110
• Other study ID #: A-FR-52014-228
• Status: Completed
• Start date: March 9, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 831
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Ipsen Central Contact	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Health status scores as evaluated by G8 questionnaire		Baseline and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cognitive status scores as evaluated by Mini Mental State (MMS)		Baseline and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Autonomy question	Subjects respond either 'yes' or 'no' to the following autonomy question 'Is the patient living independently at home?'	Baseline and 6 months
Secondary	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