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Eligard Observational Registry for Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
CMX Research
ClinicalTrials.gov Identifier:
NCT00992251
First received: October 7, 2009
Last updated: December 21, 2016
Last verified: December 2016

October 7, 2009
December 21, 2016
August 2009
March 2014   (final data collection date for primary outcome measure)
Determine the percentage of patients that will achieve a hormone refractory status at 3 years after initiation of Androgen Deprivation Treatment with Eligard®. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00992251 on ClinicalTrials.gov Archive Site
  • Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Collect data on patient demographics, medical history, and change in prostate-, bone- and overall health of the patients receiving androgen ablation treatment using Eligard®. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Collect referral data if the patient was referred to a medical oncologist during treatment. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
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Eligard Observational Registry for Patients With Prostate Cancer
A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.
The objective of this registry is to collect data on patient demographics, medical history, change in prostate, bone and overall health of the patients receiving androgen ablation treatment using Eligard. Data collected through this national registry program provides an opportunity to increase knowledge of efficacy and safety of the long term treatment with Eligard, provide a platform to better identify patient segments for the therapy with Eligard®. Furthermore registries are the only tools to accurately capture rare adverse events.

354 patients were enrolled in this study. Only 88 patients completed the study.

For those patients completing the three years of data collection, 10% were considered Castrate Resistant and remained on Eligard®. For those patients not completing 3 years of follow-up, 8.8% were considered Castrate Resistant and did not continue in the study.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Patients > 18 years of age. Histologically confirmed diagnosis of locally Advanced or Metastatic Prostate Cancer Patient starting an androgen deprivation therapy with Eligard at 3 or 4 month treatment frequency per standard of care.
Cancer of the Prostate
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
354
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients > 18 years of age.
  • Histologically confirmed diagnosis of locally Advanced or Metastatic Prostate Cancer.
  • Patient starting an androgen deprivation therapy with Eligard at 3 or 4 month treatment frequency per standard of care.
  • Signed written informed consent.

Exclusion Criteria:

  • Prior ADT (within 6 months).
  • Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
  • Life expectancy less than 2 years.
Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00992251
LEUPR_L_04620
Yes
Undecided
Not Provided
CMX Research
CMX Research
Sanofi
Study Director: Hélène Grassin Sanofi
CMX Research
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP