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

NCT03516110 | Completed

• 1 other identifier: A-FR-52014-228
• Study Type: observational
• Target: 831
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• HRQOL Visual Analog Scale (VAS) score

  Baseline and 6 months

• Health status scores as evaluated by G8 questionnaire

  Baseline and 6 months

• Overall condition VAS score

  Baseline and 6 months

• Urinary function scores as evaluated by QOL question of the International Prostate Symptom Score (IPSS)

  Baseline and 6 months

• Urinary function score VAS

  Baseline and 6 months

Study Arms (3)

Prostate cancer subjects 60-<70 years

Other: Data collection

Prostate cancer subjects 70-<75 years

Other: Data collection

Prostate cancer subjects ≥ 75 years

Other: Data collection

Interventions

Data collection 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 60-<70 years; Prostate cancer subjects 70-<75 years; Prostate cancer subjects ≥ 75 years

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate Cancer subjects aged ≥ 60

You may qualify if:

• 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

You may not qualify if:

• Subject simultaneously participating in a clinical trial

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Ipsen Central Contact

Paris, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: May 4, 2018
• Study Start: March 9, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

FR (1)