Eligard Observational Registry for Patients With Prostate Cancer
This trial has been completed.
|Condition||cancer of the prostate|
|Start date||August 2009|
|End date||March 2014|
|Trial size||354 participants|
|Trial identifier||NCT00992251, LEUPR_L_04620|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Abbotsford, Canada||Dr. George Vrabec||completed|
|Kelowna, Canada||Southern Interior Medical Research Corporation||completed|
|Surrey, Canada||Dr. Cal Andreou||completed|
|Surrey, Canada||Dr. Nazif Omar||completed|
|Surrey, Canada||Dr. Herman Kwan||completed|
|Barrie, Canada||Dr. Joseph Zadra||completed|
|Brampton, Canada||Dr. Jonathan Giddens||completed|
|Brantford, Canada||Brantford Urology Research, Medical Arts Building||completed|
|Burlington, Canada||G. Kenneth Jansz Medicine Professional Corporation||completed|
|Guelph, Canada||Dr. Eric Hirshberg||completed|
|Hamilton, Canada||Dr. Anil Dapoor||completed|
|Markham, Canada||Dr. Giovanni A. DiCostanzo||completed|
|Newmarket, Canada||Dr. Morrie Liquornik||completed|
|North York, Canada||Dr. Roger Buckley||completed|
|North York, Canada||Dr. Stanley Flax||completed|
|North York, Canada||Dr. Jack Barkin||completed|
|Oakville, Canada||Dr. Richard Casey||completed|
|Orillia, Canada||Orillia Urology Associates||completed|
|Peterborough, Canada||Kawartha Urology Associates||completed|
|Peterborough, Canada||Dr. Mohamed Elharram||completed|
|Richmond Hill, Canada||Dr. Emmanuel Abara||completed|
|Sault Ste. Marie, Canada||Dr. Vinod Mathur||completed|
|Scarborough, Canada||Dr. Edward Woods||completed|
|Sudbury, Canada||Dr. Bisshwajit Bora||completed|
|Toronto, Canada||Dr. Nick Logarakis||completed|
|Toronto, Canada||Dr. Harold Kwok||completed|
|Toronto, Canada||Dr. Ashis Chawla||completed|
|Toronto, Canada||Dr. Jain Umesh||completed|
|Chicoutimi, Canada||Dr. Louis-Rene Barrette||completed|
|Greenfield Park, Canada||Dr. Mahmoud Nachabe||completed|
|Laval, Canada||Polyclinique Med Concorde||completed|
|Montreal, Canada||Dr. Thu Van Nguyen||completed|
|Montreal, Canada||Dr. Pierre Karakiewicz||completed|
|Rimouski, Canada||Dr. John Vary||completed|
|Val-d'Or, Canada||Dr. Thierry Tremblay||completed|
|Westmount, Canada||Westmount Med Bldg||completed|
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
Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years.
time frame: 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
Collect referral data if the patient was referred to a medical oncologist during treatment.
time frame: 3 years
Male participants at least 18 years old.
- 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.
- 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.
|Official title||A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.|
|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.|
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