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Eligard Observational Registry for Patients With Prostate Cancer

Information source: CMX Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer of the Prostate

Phase: N/A

Status: Active, not recruiting

Sponsored by: CMX Research

Official(s) and/or principal investigator(s):
Hélène Grassin, Study Director, Affiliation: Sanofi

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.

Clinical Details

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 design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Determine the percentage of patients that will achieve a hormone refractory status at 3 years after initiation of Androgen Deprivation Treatment with Eligard®.

Secondary outcome:

Determine what baseline patient characteristics are associated with becoming hormone refractory at 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®.

Collect referral data if the patient was referred to a medical oncologist during treatment.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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.

Locations and Contacts

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. Herman Kwan, Surrey, British Columbia V4A 4N7, Canada

Dr. Nazif Omar, Surrey, British Columbia V3V 1N1, 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. 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. Jack Barkin, North York, Ontario M6A 3B5, Canada

Dr. Roger Buckley, North York, Ontario M2J 1V1, Canada

Dr. Stanley Flax, North York, Ontario M3B 3S6, Canada

Dr. Richard Casey, Oakville, Ontario L6H 3P1, Canada

Orillia Urology Associates, Orillia, Ontario L3V 7V1, Canada

Dr. Mohamed Elharram, Peterborough, Ontario K9J 7B3, Canada

Kawartha Urology Associates, Peterborough, Ontario K9H 1T6, Canada

Dr. Emmanuel Abara, Richmond Hill, Ontario L4C 3X5, Canada

Dr. Vinod Mathur, Sault Ste. Marie, Ontario P6A 2C3, Canada

Dr. Edward Woods, Scarborough, Ontario M1P 2T7, Canada

Dr. Bisshwajit Bora, Sudbury, Ontario P3E 4T3, Canada

Dr. Ashis Chawla, Toronto, Ontario M6S 4W4, Canada

Dr. Harold Kwok, Toronto, Ontario M4X 1W4, Canada

Dr. Jain Umesh, Toronto, Ontario M6S 4W4, Canada

Dr. Nick Logarakis, Toronto, Ontario M1P 2T7, 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. Pierre Karakiewicz, Montreal, Quebec H2X 1N8, Canada

Dr. Thu Van Nguyen, Montreal, Quebec H2L 4M1, 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

Additional Information

Starting date: September 2009
Last updated: May 30, 2011

Page last updated: August 23, 2015

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