Eligard Observational Registry for Patients With Prostate Cancer

Completed

• Conditions: Cancer of the Prostate

• Registration Number: NCT00992251
• Lead Sponsor: CMX Research

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 354

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the percentage of patients that will achieve a hormone refractory status at 3 years after initiation of Androgen Deprivation Treatment with Eligard®.	3 Years

Secondary Outcome Measures

Name	Time	Method
Collect data on patient demographics, medical history, and change in prostate-, bone- and overall health of the patients receiving androgen ablation treatment using Eligard®.	3 years
Collect referral data if the patient was referred to a medical oncologist during treatment.	3 years
Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years.	3 years

Trial Locations

Locations (36)

Dr. George Vrabec; 🇨🇦 Abbotsford, British Columbia, Canada

Southern Interior Medical Research Corporation; 🇨🇦 Kelowna, British Columbia, Canada

Dr. Cal Andreou; 🇨🇦 Surrey, British Columbia, Canada

Dr. Nazif Omar; 🇨🇦 Surrey, British Columbia, Canada

Dr. Herman Kwan; 🇨🇦 Surrey, British Columbia, Canada

Dr. Joseph Zadra; 🇨🇦 Barrie, Ontario, Canada

Dr. Jonathan Giddens; 🇨🇦 Brampton, Ontario, Canada

Brantford Urology Research, Medical Arts Building; 🇨🇦 Brantford, Ontario, Canada

G. Kenneth Jansz Medicine Professional Corporation; 🇨🇦 Burlington, Ontario, Canada

Dr. Eric Hirshberg; 🇨🇦 Guelph, Ontario, Canada

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