Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer (CHRONOS3)
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|ClinicalTrials.gov Identifier: NCT02238366|
Recruitment Status : Active, not recruiting
First Posted : September 12, 2014
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Drug: triptorelin|
|Study Type :||Observational|
|Actual Enrollment :||368 participants|
|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|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Prostate cancer patients
Patients recently diagnosed with prostate cancer requiring ADT.
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
- 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.
- 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).
- 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)].
- 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)].
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
|Study Director:||Ipsen Medical Director||Ipsen|