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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

831 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-09

Study Completion Date

2020-02-28

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.

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prostate cancer subjects 60-<70 years

Data collection

Intervention Type OTHER

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

Data collection

Intervention Type OTHER

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

Data collection

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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

Minimum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No