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Eligard Observational Registry for Patients With Prostate Cancer

NCT ID: NCT00992251

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Cancer of the Prostate

Keywords

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prostate cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

CMX Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hélène Grassin

Role: STUDY_DIRECTOR

Sanofi

Locations

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Dr. George Vrabec

Abbotsford, British Columbia, Canada

Site Status

Southern Interior Medical Research Corporation

Kelowna, British Columbia, Canada

Site Status

Dr. Cal Andreou

Surrey, British Columbia, Canada

Site Status

Dr. Nazif Omar

Surrey, British Columbia, Canada

Site Status

Dr. Herman Kwan

Surrey, British Columbia, Canada

Site Status

Dr. Joseph Zadra

Barrie, Ontario, Canada

Site Status

Dr. Jonathan Giddens

Brampton, Ontario, Canada

Site Status

Brantford Urology Research, Medical Arts Building

Brantford, Ontario, Canada

Site Status

G. Kenneth Jansz Medicine Professional Corporation

Burlington, Ontario, Canada

Site Status

Dr. Bisshwajit Bora

Greater Sudbury, Ontario, Canada

Site Status

Dr. Eric Hirshberg

Guelph, Ontario, Canada

Site Status

Dr. Anil Dapoor

Hamilton, Ontario, Canada

Site Status

Dr. Giovanni A. DiCostanzo

Markham, Ontario, Canada

Site Status

Dr. Morrie Liquornik

Newmarket, Ontario, Canada

Site Status

Dr. Roger Buckley

North York, Ontario, Canada

Site Status

Dr. Stanley Flax

North York, Ontario, Canada

Site Status

Dr. Jack Barkin

North York, Ontario, Canada

Site Status

Dr. Richard Casey

Oakville, Ontario, Canada

Site Status

Orillia Urology Associates

Orillia, Ontario, Canada

Site Status

Kawartha Urology Associates

Peterborough, Ontario, Canada

Site Status

Dr. Mohamed Elharram

Peterborough, Ontario, Canada

Site Status

Dr. Emmanuel Abara

Richmond Hill, Ontario, Canada

Site Status

Dr. Vinod Mathur

Sault Ste. Marie, Ontario, Canada

Site Status

Dr. Edward Woods

Scarborough Village, Ontario, Canada

Site Status

Dr. Nick Logarakis

Toronto, Ontario, Canada

Site Status

Dr. Harold Kwok

Toronto, Ontario, Canada

Site Status

Dr. Ashis Chawla

Toronto, Ontario, Canada

Site Status

Dr. Jain Umesh

Toronto, Ontario, Canada

Site Status

Dr. Louis-Rene Barrette

Chicoutimi, Quebec, Canada

Site Status

Dr. Mahmoud Nachabe

Greenfield Park, Quebec, Canada

Site Status

Polyclinique Med Concorde

Laval, Quebec, Canada

Site Status

Dr. Thu Van Nguyen

Montreal, Quebec, Canada

Site Status

Dr. Pierre Karakiewicz

Montreal, Quebec, Canada

Site Status

Dr. John Vary

Rimouski, Quebec, Canada

Site Status

Dr. Thierry Tremblay

Val-d'Or, Quebec, Canada

Site Status

Westmount Med Bldg

Westmount, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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LEUPR_L_04620

Identifier Type: -

Identifier Source: org_study_id