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.
1 other identifier
observational
354
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2009
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 7, 2009
CompletedFirst Posted
Study publicly available on registry
October 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedDecember 22, 2016
December 1, 2016
4.6 years
October 7, 2009
December 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years.
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®.
3 years
Collect referral data if the patient was referred to a medical oncologist during treatment.
3 years
Eligibility 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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CMX Researchlead
- Sanoficollaborator
Study Sites (36)
Dr. George Vrabec
Abbotsford, British Columbia, V2S 3N5, Canada
Southern Interior Medical Research Corporation
Kelowna, British Columbia, V1Y 2H4, Canada
Dr. Cal Andreou
Surrey, British Columbia, V3V 1N1, Canada
Dr. Nazif Omar
Surrey, British Columbia, V3V 1N1, Canada
Dr. Herman Kwan
Surrey, British Columbia, V4A 4N7, Canada
Dr. Joseph Zadra
Barrie, Ontario, L4M 7G1, Canada
Dr. Jonathan Giddens
Brampton, Ontario, L6T 4S5, Canada
Brantford Urology Research, Medical Arts Building
Brantford, Ontario, N3R 4N3, Canada
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, L7N 3V2, Canada
Dr. Bisshwajit Bora
Greater Sudbury, Ontario, P3E 4T3, Canada
Dr. Eric Hirshberg
Guelph, Ontario, N1H 5J1, Canada
Dr. Anil Dapoor
Hamilton, Ontario, L8N 4A6, Canada
Dr. Giovanni A. DiCostanzo
Markham, Ontario, L6B 1A1, Canada
Dr. Morrie Liquornik
Newmarket, Ontario, L3X 1W1, Canada
Dr. Roger Buckley
North York, Ontario, M2J 1V1, Canada
Dr. Stanley Flax
North York, Ontario, M3B 3S6, Canada
Dr. Jack Barkin
North York, Ontario, M6A 3B5, Canada
Dr. Richard Casey
Oakville, Ontario, L6H 3P1, Canada
Orillia Urology Associates
Orillia, Ontario, L3V 7V1, Canada
Kawartha Urology Associates
Peterborough, Ontario, K9H 1T6, Canada
Dr. Mohamed Elharram
Peterborough, Ontario, K9J 7B3, Canada
Dr. Emmanuel Abara
Richmond Hill, Ontario, L4C 3X5, Canada
Dr. Vinod Mathur
Sault Ste. Marie, Ontario, P6A 2C3, Canada
Dr. Edward Woods
Scarborough Village, Ontario, M1P 2T7, Canada
Dr. Nick Logarakis
Toronto, Ontario, M1P 2T7, Canada
Dr. Harold Kwok
Toronto, Ontario, M4X 1W4, Canada
Dr. Ashis Chawla
Toronto, Ontario, M6S 4W4, Canada
Dr. Jain Umesh
Toronto, Ontario, M6S 4W4, Canada
Dr. Louis-Rene Barrette
Chicoutimi, Quebec, G7H 4J1, Canada
Dr. Mahmoud Nachabe
Greenfield Park, Quebec, J4V 2H3, Canada
Polyclinique Med Concorde
Laval, Quebec, H7G 2E6, Canada
Dr. Thu Van Nguyen
Montreal, Quebec, H2L 4M1, Canada
Dr. Pierre Karakiewicz
Montreal, Quebec, H2X 1N8, Canada
Dr. John Vary
Rimouski, Quebec, G5L 8W1, Canada
Dr. Thierry Tremblay
Val-d'Or, Quebec, J9P 3Y1, Canada
Westmount Med Bldg
Westmount, Quebec, H4A 1S9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hélène Grassin
Sanofi
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2009
First Posted
October 9, 2009
Study Start
August 1, 2009
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
December 22, 2016
Record last verified: 2016-12