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Trial record 2 of 2 for:    CHRONOS-3

Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer (CHRONOS3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02238366
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease Intervention/treatment
Prostate Cancer Drug: triptorelin

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Study Type : Observational
Actual Enrollment : 368 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : November 2013
Actual Primary Completion Date : June 6, 2019
Actual Study Completion Date : June 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Prostate cancer patients
Patients recently diagnosed with prostate cancer requiring ADT.
Drug: 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.
Other Name: Diphereline 3.75mg or Diphereline PR (prolonged release) 11.25mg intramuscular (IM.) Injection




Primary Outcome Measures :
  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 Outcome Measures :
  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)].



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men recently diagnosed with locally advanced or metastatic prostate cancer receiving ADT.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238366


Locations
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Romania
Arad, Romania
Bucharest, Romania
Cluj-Napoca, Romania
Constanta, Romania
Craiova, Romania
Iasi, Romania
Timisoara, Romania
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02238366     History of Changes
Other Study ID Numbers: A-38-52014-213
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents