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Completed

NCT Number: NCT03516110

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

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

60 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Ipsen Central Contact

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Quality of Life (QOL) as evaluated by Quality of Life Questionnaire-Elderly 14 items (QLQ-ELD-14)

    Time frame: Change from baseline at 6 months

    Evolution overall and in subgroups of age ([60-<70], [70- <75] and ≥ 75 years).

Secondary outcomes

  1. HRQOL Visual Analog Scale (VAS) score

    Time frame: Baseline and 6 months

    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'.

  2. Health status scores as evaluated by G8 questionnaire

    Time frame: Baseline and 6 months

  3. Overall condition VAS score

    Time frame: Baseline and 6 months

    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'.

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

    Time frame: Baseline and 6 months

    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).

  5. Urinary function score VAS

    Time frame: Baseline and 6 months

    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'.

  6. 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

    Time frame: Baseline and 6 months

  7. Sexual function VAS score

    Time frame: Baseline and 6 months

    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'.

  8. Cognitive status scores as evaluated by Mini Mental State (MMS)

    Time frame: Baseline and 6 months

  9. Memory VAS score

    Time frame: Baseline and 6 months

    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'.

  10. Mood scores as evaluated by mini Geriatric Depression Scale (GDS) questionnaire

    Time frame: Baseline and 6 months

    Subjects will be asked four questions and their responses 'Yes' or 'No' will be scored from 0 to 1.

  11. Mood VAS score

    Time frame: Baseline and 6 months

    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'.

  12. Motricity scores as evaluated by G8 questionnaire specific domain (3rd item)

    Time frame: Baseline and 6 months

    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

  13. VAS motricity score

    Time frame: Baseline and 6 months

    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'

  14. Autonomy question

    Time frame: Baseline and 6 months

    Subjects respond either 'yes' or 'no' to the following autonomy question 'Is the patient living independently at home?'

  15. Autonomy VAS score

    Time frame: Baseline and 6 months

    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'.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: PRISME

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 4, 2018
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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