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Completed

NCT Number: NCT02238366

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

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Arad, Romania

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Percentage of patients for whom the initial Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed.

    Time frame: 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.

  2. Percentage of patients for whom the initial GnRH analogue formulation has been renewed.

    Time frame: 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 outcomes

  1. Percentage of patients for whom the initial GnRH analogue formulation has been renewed at each follow up visit

    Time frame: 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)].

  2. Percentage of patients that switched from a 1-month to a 3-months formulation

    Time frame: 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)].

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Non-interventional, Multi-centric, Observational, Prospective Study to Collect the Criteria on Which Renewal of GnRH Analogue Treatment With Triptorelin (Diphereline 3.75mg or Diphereline pr 11.25mg) is Made in Patients Recently Diagnosed With Prostate Cancer Requiring Androgen Deprivation Therapy

Acronym: CHRONOS3

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2014
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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