Cancer of the Prostate Clinical Trial
Official title:
A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.
Verified date | December 2016 |
Source | CMX Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 354 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Dr. George Vrabec | Abbotsford | British Columbia |
Canada | Dr. Joseph Zadra | Barrie | Ontario |
Canada | Dr. Jonathan Giddens | Brampton | Ontario |
Canada | Brantford Urology Research, Medical Arts Building | Brantford | Ontario |
Canada | G. Kenneth Jansz Medicine Professional Corporation | Burlington | Ontario |
Canada | Dr. Louis-Rene Barrette | Chicoutimi | Quebec |
Canada | Dr. Mahmoud Nachabe | Greenfield Park | Quebec |
Canada | Dr. Eric Hirshberg | Guelph | Ontario |
Canada | Dr. Anil Dapoor | Hamilton | Ontario |
Canada | Southern Interior Medical Research Corporation | Kelowna | British Columbia |
Canada | Polyclinique Med Concorde | Laval | Quebec |
Canada | Dr. Giovanni A. DiCostanzo | Markham | Ontario |
Canada | Dr. Pierre Karakiewicz | Montreal | Quebec |
Canada | Dr. Thu Van Nguyen | Montreal | Quebec |
Canada | Dr. Morrie Liquornik | Newmarket | Ontario |
Canada | Dr. Jack Barkin | North York | Ontario |
Canada | Dr. Roger Buckley | North York | Ontario |
Canada | Dr. Stanley Flax | North York | Ontario |
Canada | Dr. Richard Casey | Oakville | Ontario |
Canada | Orillia Urology Associates | Orillia | Ontario |
Canada | Dr. Mohamed Elharram | Peterborough | Ontario |
Canada | Kawartha Urology Associates | Peterborough | Ontario |
Canada | Dr. Emmanuel Abara | Richmond Hill | Ontario |
Canada | Dr. John Vary | Rimouski | Quebec |
Canada | Dr. Vinod Mathur | Sault Ste. Marie | Ontario |
Canada | Dr. Edward Woods | Scarborough | Ontario |
Canada | Dr. Bisshwajit Bora | Sudbury | Ontario |
Canada | Dr. Cal Andreou | Surrey | British Columbia |
Canada | Dr. Herman Kwan | Surrey | British Columbia |
Canada | Dr. Nazif Omar | Surrey | British Columbia |
Canada | Dr. Ashis Chawla | Toronto | Ontario |
Canada | Dr. Harold Kwok | Toronto | Ontario |
Canada | Dr. Jain Umesh | Toronto | Ontario |
Canada | Dr. Nick Logarakis | Toronto | Ontario |
Canada | Dr. Thierry Tremblay | Val-d'Or | Quebec |
Canada | Westmount Med Bldg | Westmount | Quebec |
Lead Sponsor | Collaborator |
---|---|
CMX Research | Sanofi |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the percentage of patients that will achieve a hormone refractory status at 3 years after initiation of Androgen Deprivation Treatment with Eligard®. | 3 Years | No | |
Secondary | Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years. | 3 years | No | |
Secondary | Collect data on patient demographics, medical history, and change in prostate-, bone- and overall health of the patients receiving androgen ablation treatment using Eligard®. | 3 years | No | |
Secondary | Collect referral data if the patient was referred to a medical oncologist during treatment. | 3 years | No |
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