Clinical trial NCT03516110: Health Related Quality of Life and Multidimensional Evaluations of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-05-04
Enrollment: 831
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate Cancer subjects aged ≥ 60

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life (QOL) as evaluated by Quality of Life Questionnaire-Elderly 14 items (QLQ-ELD-14)
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: HRQOL Visual Analog Scale (VAS) score
timeFrame: Baseline and 6 months
measure: Health status scores as evaluated by G8 questionnaire
timeFrame: Baseline and 6 months
measure: Overall condition VAS score
timeFrame: Baseline and 6 months
measure: Urinary function scores as evaluated by QOL question of the International Prostate Symptom Score (IPSS)
timeFrame: Baseline and 6 months
measure: Urinary function score VAS
timeFrame: Baseline and 6 months
measure: 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
timeFrame: Baseline and 6 months
measure: Sexual function VAS score
timeFrame: Baseline and 6 months
measure: Cognitive status scores as evaluated by Mini Mental State (MMS)
timeFrame: Baseline and 6 months
measure: Memory VAS score
timeFrame: Baseline and 6 months
measure: Mood scores as evaluated by mini Geriatric Depression Scale (GDS) questionnaire
timeFrame: Baseline and 6 months
measure: Mood VAS score
timeFrame: Baseline and 6 months
measure: Motricity scores as evaluated by G8 questionnaire specific domain (3rd item)
timeFrame: Baseline and 6 months
measure: VAS motricity score
timeFrame: Baseline and 6 months
measure: Autonomy question
timeFrame: Baseline and 6 months
measure: Autonomy VAS score
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Ipsen Central Contact
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: