Clinical trial NCT00992251: Eligard Observational Registry for Patients With Prostate Cancer
Official title: A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Prostate
Keywords: prostate cancer
Lead sponsor: CMX Research
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2009-10-09
Enrollment: 354
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the percentage of patients that will achieve a hormone refractory status at 3 years after initiation of Androgen Deprivation Treatment with Eligard®.
timeFrame: 3 Years
Secondary outcomes:
measure: Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years.
timeFrame: 3 years
measure: Collect data on patient demographics, medical history, and change in prostate-, bone- and overall health of the patients receiving androgen ablation treatment using Eligard®.
timeFrame: 3 years
measure: Collect referral data if the patient was referred to a medical oncologist during treatment.
timeFrame: 3 years
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: Dr. George Vrabec
state: British Columbia
city: Kelowna
country: Canada
facility: Southern Interior Medical Research Corporation
state: British Columbia
city: Surrey
country: Canada
facility: Dr. Cal Andreou
state: British Columbia
city: Surrey
country: Canada
facility: Dr. Nazif Omar
state: British Columbia
city: Surrey
country: Canada
facility: Dr. Herman Kwan
state: British Columbia
city: Barrie
country: Canada
facility: Dr. Joseph Zadra
state: Ontario
city: Brampton
country: Canada
facility: Dr. Jonathan Giddens
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research, Medical Arts Building
state: Ontario
city: Burlington
country: Canada
facility: G. Kenneth Jansz Medicine Professional Corporation
state: Ontario
city: Guelph
country: Canada
facility: Dr. Eric Hirshberg
state: Ontario
city: Hamilton
country: Canada
facility: Dr. Anil Dapoor
state: Ontario
city: Markham
country: Canada
facility: Dr. Giovanni A. DiCostanzo
state: Ontario
city: Newmarket
country: Canada
facility: Dr. Morrie Liquornik
state: Ontario
city: North York
country: Canada
facility: Dr. Roger Buckley
state: Ontario
city: North York
country: Canada
facility: Dr. Stanley Flax
state: Ontario
city: North York
country: Canada
facility: Dr. Jack Barkin
state: Ontario
city: Oakville
country: Canada
facility: Dr. Richard Casey
state: Ontario
city: Orillia
country: Canada
facility: Orillia Urology Associates
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Urology Associates
state: Ontario
city: Peterborough
country: Canada
facility: Dr. Mohamed Elharram
state: Ontario
city: Richmond Hill
country: Canada
facility: Dr. Emmanuel Abara
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Dr. Vinod Mathur
state: Ontario
city: Scarborough
country: Canada
facility: Dr. Edward Woods
state: Ontario
city: Sudbury
country: Canada
facility: Dr. Bisshwajit Bora
state: Ontario
city: Toronto
country: Canada
facility: Dr. Nick Logarakis
state: Ontario
city: Toronto
country: Canada
facility: Dr. Harold Kwok
state: Ontario
city: Toronto
country: Canada
facility: Dr. Ashis Chawla
state: Ontario
city: Toronto
country: Canada
facility: Dr. Jain Umesh
state: Ontario
city: Chicoutimi
country: Canada
facility: Dr. Louis-Rene Barrette
state: Quebec
city: Greenfield Park
country: Canada
facility: Dr. Mahmoud Nachabe
state: Quebec
city: Laval
country: Canada
facility: Polyclinique Med Concorde
state: Quebec
city: Montreal
country: Canada
facility: Dr. Thu Van Nguyen
state: Quebec
city: Montreal
country: Canada
facility: Dr. Pierre Karakiewicz
state: Quebec
city: Rimouski
country: Canada
facility: Dr. John Vary
state: Quebec
city: Val-d'Or
country: Canada
facility: Dr. Thierry Tremblay
state: Quebec
city: Westmount
country: Canada
facility: Westmount Med Bldg
state: Quebec
Study officials:
affiliation: Sanofi
name: Hélène Grassin
role: STUDY_DIRECTOR
References: