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

Ipsen831 enrolled

Overview

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.

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

831

Conditions

Prostate Cancer

Interventions

Data collectionOTHER

Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional assessments or tests will be required.

Eligibility

Sex: MALEMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Ipsen Central Contact

Paris, France

Outcomes

Primary Outcomes

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).

Time frame: Change from baseline at 6 months

Secondary Outcomes

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'.