Prostate Cancer
Conditions
Brief summary
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.
Interventions
DRUGtriptorelin
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.
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3 month GnRH analogue triptorelin formulation * Expected survival \> 12 months. * Patients having provided written informed consent. * Patients mentally fit for completing a questionnaire.
Exclusion criteria
* Treatment with any investigational drug within the last 3 months before study entry or planning to participate in a study. * Patients who already have been treated with a GnRH analogue within the last year. * Patients with hypersensitivity to GnRH, GnRH analogue, triptorelin or its excipients. * Patients with a contraindication according to SmPC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients for whom the initial Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed. | 1 month | 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. |
| Percentage of patients for whom the initial GnRH analogue formulation has been renewed. | 3 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients for whom the initial GnRH analogue formulation has been renewed at each follow up visit | 6 and 12 months | To evaluate the percentage of patients for whom the initial GnRH formulation (triptorelin-Diphereline®) had been renewed at each follow up visit \[Visit 3 (at 6-months +/- 3 weeks), Visit 4 (at 12-months +/- 6 weeks)\]. |
| Percentage of patients that switched from a 1-month to a 3-months formulation | 3, 6, 12 months | To evaluate the percentage of patients having switched from a 1-month to a 3-months formulation at each visit \[Visit 2 (at 1 month or 3 months), Visit 3 (at 6 months +/- 3 weeks), Visit 4 (at 12 months +/- 6 weeks)\]. |
Countries
Romania
Outcome results
None listed