Overview

This trial is active, not recruiting.

Condition cancer of the prostate
Sponsor CMX Research
Collaborator Sanofi
Start date September 2009
Trial size 330 participants
Trial identifier NCT00992251, LEUPR_L_04620

Summary

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

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

Secondary Outcomes

Measure
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by CMX Research.