Eligard Observational Registry for Patients With Prostate Cancer

December 21, 2016 updated by: CMX Research

A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

354

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3N5
        • Dr. George Vrabec
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Southern Interior Medical Research Corporation
      • Surrey, British Columbia, Canada, V3V 1N1
        • Dr. Cal Andreou
      • Surrey, British Columbia, Canada, V3V 1N1
        • Dr. Nazif Omar
      • Surrey, British Columbia, Canada, V4A 4N7
        • Dr. Herman Kwan
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Dr. Joseph Zadra
      • Brampton, Ontario, Canada, L6T 4S5
        • Dr. Jonathan Giddens
      • Brantford, Ontario, Canada, N3R 4N3
        • Brantford Urology Research, Medical Arts Building
      • Burlington, Ontario, Canada, L7N 3V2
        • G. Kenneth Jansz Medicine Professional Corporation
      • Guelph, Ontario, Canada, N1H 5J1
        • Dr. Eric Hirshberg
      • Hamilton, Ontario, Canada, L8N 4A6
        • Dr. Anil Dapoor
      • Markham, Ontario, Canada, L6B 1A1
        • Dr. Giovanni A. DiCostanzo
      • Newmarket, Ontario, Canada, L3X 1W1
        • Dr. Morrie Liquornik
      • North York, Ontario, Canada, M2J 1V1
        • Dr. Roger Buckley
      • North York, Ontario, Canada, M3B 3S6
        • Dr. Stanley Flax
      • North York, Ontario, Canada, M6A 3B5
        • Dr. Jack Barkin
      • Oakville, Ontario, Canada, L6H 3P1
        • Dr. Richard Casey
      • Orillia, Ontario, Canada, L3V 7V1
        • Orillia Urology Associates
      • Peterborough, Ontario, Canada, K9H 1T6
        • Kawartha Urology Associates
      • Peterborough, Ontario, Canada, K9J 7B3
        • Dr. Mohamed Elharram
      • Richmond Hill, Ontario, Canada, L4C 3X5
        • Dr. Emmanuel Abara
      • Sault Ste. Marie, Ontario, Canada, P6A 2C3
        • Dr. Vinod Mathur
      • Scarborough, Ontario, Canada, M1P 2T7
        • Dr. Edward Woods
      • Sudbury, Ontario, Canada, P3E 4T3
        • Dr. Bisshwajit Bora
      • Toronto, Ontario, Canada, M1P 2T7
        • Dr. Nick Logarakis
      • Toronto, Ontario, Canada, M4X 1W4
        • Dr. Harold Kwok
      • Toronto, Ontario, Canada, M6S 4W4
        • Dr. Ashis Chawla
      • Toronto, Ontario, Canada, M6S 4W4
        • Dr. Jain Umesh
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 4J1
        • Dr. Louis-Rene Barrette
      • Greenfield Park, Quebec, Canada, J4V 2H3
        • Dr. Mahmoud Nachabe
      • Laval, Quebec, Canada, H7G 2E6
        • Polyclinique Med Concorde
      • Montreal, Quebec, Canada, H2L 4M1
        • Dr. Thu Van Nguyen
      • Montreal, Quebec, Canada, H2X 1N8
        • Dr. Pierre Karakiewicz
      • Rimouski, Quebec, Canada, G5L 8W1
        • Dr. John Vary
      • Val-d'Or, Quebec, Canada, J9P 3Y1
        • Dr. Thierry Tremblay
      • Westmount, Quebec, Canada, H4A 1S9
        • Westmount Med Bldg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 Years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMX Research

Collaborators

Sanofi

Investigators

  • Study Director: Hélène Grassin, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 8, 2009

First Posted (Estimate)

October 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEUPR_L_04620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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