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| Name | Class |
|---|---|
| Veeda Clinical Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate Cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depo-Eligard® | Drug | Subcutaneous |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of tolerability of treatment on a 4 point scale | Last Visit (after at least 180 days of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Drug Reactions | Day 1 and Last Visit (after at least 180 days of treatment) | |
| Investigator satisfaction with treatment | Last Visit (after at least 180 days of treatment) | |
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Inclusion Criteria:
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Consultation at urology department
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site: 5 | Antwerp | Antwerp | 2018 | Belgium | ||
| Site: 8 |
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| Overall patient's assessment of treatment benefit |
| 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) | 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 | 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 | Day 1 and Last Visit (after at least 180 days of treatment) |
| Antwerp |
| Antwerp |
| 2018 |
| Belgium |
| Site: 9 | Antwerp | Antwerp | 2018 | Belgium |
| Site: 14 | Antwerp | Antwerp | 2020 | Belgium |
| Site: 4 | Antwerp | Antwerp | 2200 | Belgium |
| Site: 33 | Merksem | Antwerp | 2170 | Belgium |
| Site: 1 | Turnhout | Antwerp | 2300 | Belgium |
| Site: 23 | Brussels | Brussels Capital | 1030 | Belgium |
| Site: 13 | Brussels | Brussels Capital | 1090 | Belgium |
| Site: 24 | Uccle | Brussels Capital | 1180 | Belgium |
| Site: 32 | Aalst | East Flanders | 9300 | Belgium |
| Site: 34 | Dendermonde | East Flanders | 9200 | Belgium |
| Site: 11 | Ghent | East Flanders | 9000 | Belgium |
| Site: 17 | Oudenaarde | East Flanders | 9700 | Belgium |
| Site: 18 | Tienen | Flemish Brabant | 3300 | Belgium |
| Site: 39 | La Louvière | Hainaut | 7100 | Belgium |
| Site: 37 | Sint-Truiden | Limburg | 3800 | Belgium |
| Site: 38 | Liège | Liège | 4000 | Belgium |
| Site: 26 | Lasne-Chapelle-Saint-Lambert | Walloon Brabant | 1380 | Belgium |
| Site: 21 | Ieper | West Flanders | 8900 | Belgium |
| Site: 20 | Izegem | West Flanders | 8870 | Belgium |
| Site: 25 | Kortijk | West Flanders | 8500 | Belgium |
| Site: 31 | Ostend | West Flanders | 8400 | Belgium |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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