This trial has been completed.

Condition cancer of the prostate
Sponsor CMX Research
Collaborator Sanofi
Start date August 2009
End date March 2014
Trial size 354 participants
Trial identifier NCT00992251, LEUPR_L_04620


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

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

Secondary Outcomes

Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years.
time frame: 3 years
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
Collect referral data if the patient was referred to a medical oncologist during treatment.
time frame: 3 years

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

Official title A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by CMX Research.