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

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ClinicalTrials.gov Identifier: NCT03516110
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease Intervention/treatment
Prostate Cancer Other: Data collection

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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
Actual Study Start Date : March 9, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Prostate cancer subjects 60-<70 years Other: 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.

Prostate cancer subjects 70-<75 years Other: 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.

Prostate cancer subjects ≥ 75 years Other: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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'.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prostate Cancer subjects aged ≥ 60
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516110


Contacts
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Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
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France
Ipsen Central Contact Recruiting
Paris, France
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

Additional Information:

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03516110     History of Changes
Other Study ID Numbers: A-FR-52014-228
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs