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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 : Active, not recruiting
First Posted : September 12, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date September 2, 2014
First Posted Date September 12, 2014
Last Update Posted Date February 15, 2019
Study Start Date November 2013
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 4, 2015)
  • 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).
Original Primary Outcome Measures
 (submitted: September 10, 2014)
  • Percentage of patients for whom the initial 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).
Change History Complete list of historical versions of study NCT02238366 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 10, 2014)
  • 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)].
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Men recently diagnosed with locally advanced or metastatic prostate cancer receiving ADT.
Condition Prostate Cancer
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.
Other Name: Diphereline 3.75mg or Diphereline PR (prolonged release) 11.25mg intramuscular (IM.) Injection
Study Groups/Cohorts Prostate cancer patients
Patients recently diagnosed with prostate cancer requiring ADT.
Intervention: Drug: triptorelin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 12, 2018)
368
Original Estimated Enrollment
 (submitted: September 10, 2014)
369
Estimated Study Completion Date June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Romania
Removed Location Countries  
 
Administrative Information
NCT Number NCT02238366
Other Study ID Numbers A-38-52014-213
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date February 2019