Eligard Observational Registry for Patients With Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by CMX Research.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
CMX Research
ClinicalTrials.gov Identifier:
NCT00992251
First received: October 7, 2009
Last updated: May 30, 2011
Last verified: May 2011
  Purpose

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.


Condition
Cancer of the Prostate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.

Resource links provided by NLM:


Further study details as provided by CMX Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Collect referral data if the patient was referred to a medical oncologist during treatment. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: September 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992251

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

No publications provided

Responsible Party: Zsuzsanna Gesztesi, CMX Research Inc.
ClinicalTrials.gov Identifier: NCT00992251     History of Changes
Other Study ID Numbers: LEUPR_L_04620
Study First Received: October 7, 2009
Last Updated: May 30, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by CMX Research:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014