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

Prostate Cancer Clinical Trial

— CHRONOS3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238366
• Other study ID #: A-38-52014-213
• Status: Completed
• Start date: November 2013
• Est. completion date: June 6, 2019

Study information

• Verified date: July 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Primary	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).	3 months
Secondary	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)].	6 and 12 months
Secondary	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)].	3, 6, 12 months