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
Recruitment status was Active, not recruiting
Sponsor:
CMX Research
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
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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
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 May 19, 2013