Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer

Ipsen368 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

368

Conditions

Prostate Cancer

Interventions

triptorelinDRUG

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Unnamed facility

Arad, Romania

Unnamed facility

Bucharest, Romania

Unnamed facility

Cluj-Napoca, Romania

Unnamed facility

Constanța, Romania

Unnamed facility

Craiova, Romania

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 3 months

Secondary Outcomes

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 \[Visit 3 (at 6-months +/- 3 weeks), Visit 4 (at 12-months +/- 6 weeks)\].

Time frame: 6 and 12 months

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 \[Visit 2 (at 1 month or 3 months), Visit 3 (at 6 months +/- 3 weeks), Visit 4 (at 12 months +/- 6 weeks)\].

Time frame: 3, 6, 12 months

Data from ClinicalTrials.gov

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