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The purpose of this study is to collect some parameters which may help to provide guidance on how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate cancer patients | Patients recently diagnosed with prostate cancer requiring ADT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triptorelin | Drug | This is an observational study. Thus, the treatment selection with triptorelin (Diphereline® or Diphereline PR®) is at investigator's discretion based on the current practice principles and guidelines/protocols, in accordance with the Summary of Product Characteristics (SmPC) approved in Romania by the National Medicines Agency. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients for whom the initial Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed. | To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at 1-month +/- 7 days for Diphereline 3.75mg. | 1 month |
| Percentage of patients for whom the initial GnRH analogue formulation has been renewed. | To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at at 3-months +/- 10 days for Diphereline PR 11.25mg (Visit 2). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients for whom the initial GnRH analogue formulation has been renewed at each follow up visit | To evaluate the percentage of patients for whom the initial GnRH formulation (triptorelin-Diphereline®) had been renewed at each follow up visit [Visit 3 (at 6-months +/- 3 weeks), Visit 4 (at 12-months +/- 6 weeks)]. | 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Men recently diagnosed with locally advanced or metastatic prostate cancer receiving ADT.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arad | Romania | |||||
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| D007273 | Injections, Intramuscular |
| D007267 | Injections |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Percentage of patients that switched from a 1-month to a 3-months formulation | To evaluate the percentage of patients having switched from a 1-month to a 3-months formulation at each visit [Visit 2 (at 1 month or 3 months), Visit 3 (at 6 months +/- 3 weeks), Visit 4 (at 12 months +/- 6 weeks)]. | 3, 6, 12 months |
| Bucharest |
| Romania |
| Cluj-Napoca | Romania |
| Constanța | Romania |
| Craiova | Romania |
| Iași | Romania |
| Timișoara | Romania |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| 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 |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |