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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00992251
Other study ID # LEUPR_L_04620
Secondary ID
Status Completed
Phase N/A
First received October 7, 2009
Last updated December 21, 2016
Start date August 2009
Est. completion date March 2014

Study information

Verified date December 2016
Source CMX Research
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 354
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Dr. George Vrabec Abbotsford 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. Louis-Rene Barrette Chicoutimi Quebec
Canada Dr. Mahmoud Nachabe Greenfield Park Quebec
Canada Dr. Eric Hirshberg Guelph Ontario
Canada Dr. Anil Dapoor Hamilton Ontario
Canada Southern Interior Medical Research Corporation Kelowna British Columbia
Canada Polyclinique Med Concorde Laval Quebec
Canada Dr. Giovanni A. DiCostanzo Markham Ontario
Canada Dr. Pierre Karakiewicz Montreal Quebec
Canada Dr. Thu Van Nguyen Montreal Quebec
Canada Dr. Morrie Liquornik Newmarket Ontario
Canada Dr. Jack Barkin North York Ontario
Canada Dr. Roger Buckley North York Ontario
Canada Dr. Stanley Flax North York Ontario
Canada Dr. Richard Casey Oakville Ontario
Canada Orillia Urology Associates Orillia Ontario
Canada Dr. Mohamed Elharram Peterborough Ontario
Canada Kawartha Urology Associates Peterborough Ontario
Canada Dr. Emmanuel Abara Richmond Hill Ontario
Canada Dr. John Vary Rimouski Quebec
Canada Dr. Vinod Mathur Sault Ste. Marie Ontario
Canada Dr. Edward Woods Scarborough Ontario
Canada Dr. Bisshwajit Bora Sudbury Ontario
Canada Dr. Cal Andreou Surrey British Columbia
Canada Dr. Herman Kwan Surrey British Columbia
Canada Dr. Nazif Omar Surrey British Columbia
Canada Dr. Ashis Chawla Toronto Ontario
Canada Dr. Harold Kwok Toronto Ontario
Canada Dr. Jain Umesh Toronto Ontario
Canada Dr. Nick Logarakis Toronto Ontario
Canada Dr. Thierry Tremblay Val-d'Or Quebec
Canada Westmount Med Bldg Westmount Quebec

Sponsors (2)

Lead Sponsor Collaborator
CMX Research Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years. 3 years No
Secondary 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 No
Secondary Collect referral data if the patient was referred to a medical oncologist during treatment. 3 years No
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