Prostate CancerTREMODINCT01793077
Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients
An observational study of Prostate Cancer, run by Astellas Pharma Europe B.V. at 23 sites in Belgium.
Trial summary
Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Depo-Eligard®
- Type of treatment
- Injection or infusion
- How many people
- 259 participants
- Where
- 23 sitesBelgium
- Study dates
- Dec 2011to Dec 2013
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consultation at urology department
Who may be able to join
- Patients having been prescribed Depo-Eligard® 7.5 mg - 22.5 mg - 45 mg in accordance with the terms of the marketing authorization.
Who cannot join
None listed.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Belgium23 sites
Site: 32
Aalst, East Flanders, 9300
Site: 5
Antwerp, Antwerp, 2018
Site: 8
Antwerp, Antwerp, 2018
Site: 9
Antwerp, Antwerp, 2018
Site: 14
Antwerp, Antwerp, 2020
Site: 4
Antwerp, Antwerp, 2200
Site: 23
Brussels, Brussels Capital, 1030
Site: 13
Brussels, Brussels Capital, 1090
Site: 34
Dendermonde, East Flanders, 9200
Site: 11
Ghent, East Flanders, 9000
Site: 21
Ieper, West Flanders, 8900
Site: 20
Izegem, West Flanders, 8870
Site: 25
Kortijk, West Flanders, 8500
Site: 39
La Louvière, Hainaut, 7100
Site: 26
Lasne-Chapelle-Saint-Lambert, Walloon Brabant, 1380
Site: 38
Liège, Liège, 4000
Site: 33
Merksem, Antwerp, 2170
Site: 31
Ostend, West Flanders, 8400
Site: 17
Oudenaarde, East Flanders, 9700
Site: 37
Sint-Truiden, Limburg, 3800
Site: 18
Tienen, Flemish Brabant, 3300
Site: 1
Turnhout, Antwerp, 2300
Site: 24
Uccle, Brussels Capital, 1180
About this study
Official title: Phase IV, Non-interventional, Prospective, Open Label, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients
Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients.
Once the examining physician has decided on the therapeutic approach and if the selection criteria are fulfilled, he will propose the patient to participate in the study. An informed consent form will be collected for all participants in the study.
Read more
There are 2 possible study visits that coincide with a routine consultation, namely visit 1 (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment benefit of the patient.
Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both visits, if available.
- Conditions
- Prostate Cancer
- Being tested
- Depo-Eligard®
- Keywords
- Prostate Cancer, Phase 4, Data collection, Observational, Depo-Eligard, Prospective, Non-interventional, Treatment
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depo-Eligard®Drug
Also called Leuprolide Acetate
Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer patients | Not described Receives: Drug: Depo-Eligard® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of tolerability of treatment on a 4 point scale
Measured: Last Visit (after at least 180 days of treatment)
Secondary outcomes (6)
Occurrence of Adverse Drug Reactions
Measured: Day 1 and Last Visit (after at least 180 days of treatment)
Investigator satisfaction with treatment
Measured: Last Visit (after at least 180 days of treatment)
Overall patient's assessment of treatment benefit
Measured: Last Visit (after at least 180 days of treatment)
Changes in quality of life of subjects as measured by EORTC QLQ-C30
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-C 30 (EORTC-QLQ-C30)
Measured: Day 1 and Last Visit (after at least 180 days of treatment)
Frequency of use of dosing schedules of Depo-Eligard® and the reasons for selecting a schedule
Measured: Day 1 and Last Visit (after at least 180 days of treatment)
Efficacy of treatment
(1) Changes in PSA and testosterone levels if available, (2) Change in disease symptoms and (3) Objective disease response
Measured: Day 1 and Last Visit (after at least 180 days of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 2013
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veeda Clinical Research
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793077
- Sponsor's protocol ID
- BE-11-EGD-04
- Acronym
- TREMODI
- Status last verified
- Jan 2014
- First submitted
- 13 Feb 2013
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Non-interventional, Prospective, Open Label, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT01793077
- Acronym / sponsor ID
- TREMODI / BE-11-EGD-04
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Phase 4, Data collection, Observational, Depo-Eligard, Prospective, Non-interventional, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Collaborators
- Veeda Clinical Research
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Feb 2013 (estimated)
- 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.
Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients.
Once the examining physician has decided on the therapeutic approach and if the selection criteria are fulfilled, he will propose the patient to participate in the study. An informed consent form will be collected for all participants in the study.
There are 2 possible study visits that coincide with a routine consultation, namely visit 1 (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment benefit of the patient.
Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both visits, if available.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer patients | – | Drug: Depo-Eligard® |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consultation at urology department
Key inclusion criteria (1 listed)
- Patients having been prescribed Depo-Eligard® 7.5 mg - 22.5 mg - 45 mg in accordance with the terms of the marketing authorization.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Depo-Eligard®Also: Leuprolide AcetateSubcutaneous | Drug | Prostate Cancer patients |
Primary outcome
Evaluation of tolerability of treatment on a 4 point scale
Time frame: Last Visit (after at least 180 days of treatment)
6 secondary outcomes
Occurrence of Adverse Drug Reactions
Time frame: Day 1 and Last Visit (after at least 180 days of treatment)
Investigator satisfaction with treatment
Time frame: Last Visit (after at least 180 days of treatment)
Overall patient's assessment of treatment benefit
Time frame: Last Visit (after at least 180 days of treatment)
Changes in quality of life of subjects as measured by EORTC QLQ-C30
Time frame: Day 1 and Last Visit (after at least 180 days of treatment)
Frequency of use of dosing schedules of Depo-Eligard® and the reasons for selecting a schedule
Time frame: Day 1 and Last Visit (after at least 180 days of treatment)
Efficacy of treatment
Time frame: Day 1 and Last Visit (after at least 180 days of treatment)
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 13 Jan 2014.
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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.
Medical Director study director
Astellas Pharma Europe B.V.
23 sites 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 Astellas Pharma Europe B.V. at 23 sites in Belgium.
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 1 inclusion and 0 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 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Belgium. 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?
Evaluation of tolerability of treatment on a 4 point scale (time frame: Last Visit (after at least 180 days of treatment)). 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 13 Jan 2014.