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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

368 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2019-06-06

Brief Summary

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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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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prostate cancer patients

Patients recently diagnosed with prostate cancer requiring ADT.

triptorelin

Intervention Type 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.

Interventions

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triptorelin

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.

Intervention Type DRUG

Other Intervention Names

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Diphereline 3.75mg or Diphereline PR (prolonged release) 11.25mg intramuscular (IM.) Injection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No