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Eligard Observational Registry for Patients With Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by CMX Research.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
CMX Research
ClinicalTrials.gov Identifier:
NCT00992251
First received: October 7, 2009
Last updated: May 30, 2011
Last verified: May 2011

October 7, 2009
May 30, 2011
September 2009
Not Provided
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
330
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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
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00992251
LEUPR_L_04620
Yes
Zsuzsanna Gesztesi, CMX Research Inc.
CMX Research
Sanofi
Study Director: Hélène Grassin Sanofi
CMX Research
May 2011

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