Prostate CancerPRISMENCT03516110
Health Related Quality of Life and Multidimensional Evaluations of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy
An observational study of Prostate Cancer, run by Ipsen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Data collection
- How many people
- 831 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2018to 28 Feb 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Prostate Cancer subjects aged ≥ 60
Who may be able to join
- 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
Who cannot join
- Subject simultaneously participating in a clinical trial
- Subject who previously received a hormonal therapy during the last 6 months before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Data collection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer subjects 60-<70 years | Not described Receives: Other: Data collection | |
| Prostate cancer subjects 70-<75 years | Not described Receives: Other: Data collection | |
| Prostate cancer subjects ≥ 75 years | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline at 6 months
Secondary outcomes (15)
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'.
Measured: Baseline and 6 months
Health status scores as evaluated by G8 questionnaire
Measured: Baseline and 6 months
Overall condition 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'.
Measured: Baseline and 6 months
Urinary function scores as evaluated by QOL question of the International Prostate Symptom Score (IPSS)
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).
Measured: Baseline and 6 months
Urinary function score VAS
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'.
Measured: Baseline and 6 months
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
Measured: Baseline and 6 months
Sexual function VAS score
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'.
Measured: Baseline and 6 months
Cognitive status scores as evaluated by Mini Mental State (MMS)
Measured: Baseline and 6 months
Memory VAS score
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'.
Measured: Baseline and 6 months
Mood scores as evaluated by mini Geriatric Depression Scale (GDS) questionnaire
Subjects will be asked four questions and their responses 'Yes' or 'No' will be scored from 0 to 1.
Measured: Baseline and 6 months
Mood VAS score
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'.
Measured: Baseline and 6 months
Motricity scores as evaluated by G8 questionnaire specific domain (3rd item)
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
Measured: Baseline and 6 months
VAS motricity score
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'
Measured: Baseline and 6 months
Autonomy question
Subjects respond either 'yes' or 'no' to the following autonomy question 'Is the patient living independently at home?'
Measured: Baseline and 6 months
Autonomy VAS score
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'.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start9 Mar 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 831 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516110
- Sponsor's protocol ID
- A-FR-52014-228
- Acronym
- PRISME
- Status last verified
- Jan 2026
- First submitted
- 9 Mar 2018
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03516110
- Acronym / sponsor ID
- PRISME / A-FR-52014-228
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate Cancer subjects aged ≥ 60
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Subject simultaneously participating in a clinical trial
- Subject who previously received a hormonal therapy during the last 6 months before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionSubjects will be treated in accordance with usual medical practice during their participation in this study. No additional assessments or tests will be required. | Other | Prostate cancer subjects 60-<70 years, Prostate cancer subjects 70-<75 years, Prostate cancer subjects ≥ 75 years |
Primary outcome
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).
15 secondary outcomes
HRQOL Visual Analog Scale (VAS) score
Time frame: Baseline and 6 months
Health status scores as evaluated by G8 questionnaire
Time frame: Baseline and 6 months
Overall condition VAS score
Time frame: Baseline and 6 months
Urinary function scores as evaluated by QOL question of the International Prostate Symptom Score (IPSS)
Time frame: Baseline and 6 months
Urinary function score VAS
Time frame: Baseline and 6 months
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
Sexual function VAS score
Time frame: Baseline and 6 months
Cognitive status scores as evaluated by Mini Mental State (MMS)
Time frame: Baseline and 6 months
Memory VAS score
Time frame: Baseline and 6 months
Mood scores as evaluated by mini Geriatric Depression Scale (GDS) questionnaire
Time frame: Baseline and 6 months
Mood VAS score
Time frame: Baseline and 6 months
Motricity scores as evaluated by G8 questionnaire specific domain (3rd item)
Time frame: Baseline and 6 months
VAS motricity score
Time frame: Baseline and 6 months
Autonomy question
Time frame: Baseline and 6 months
Autonomy VAS score
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- ArticleLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Ipsen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.