Cancer of the ProstateNCT00992251
Eligard Observational Registry for Patients With Prostate Cancer
An observational study of Cancer of the Prostate, run by CMX Research at 36 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer of the Prostate
- How many people
- 354 participants
- Where
- 36 sitesCanada
- Study dates
- Aug 2009to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Canada36 sites
Dr. George Vrabec
Abbotsford British Columbia, British Columbia, V2S 3N5
Dr. Joseph Zadra
Barrie, Ontario, L4M 7G1
Dr. Jonathan Giddens
Brampton, Ontario, L6T 4S5
Brantford Urology Research, Medical Arts Building
Brantford, Ontario, N3R 4N3
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, L7N 3V2
Dr. Louis-Rene Barrette
Chicoutimi, Quebec, G7H 4J1
Dr. Bisshwajit Bora
Greater Sudbury, Ontario, P3E 4T3
Dr. Mahmoud Nachabe
Greenfield Park, Quebec, J4V 2H3
Dr. Eric Hirshberg
Guelph, Ontario, N1H 5J1
Dr. Anil Dapoor
Hamilton, Ontario, L8N 4A6
Southern Interior Medical Research Corporation
Kelowna, British Columbia, V1Y 2H4
Polyclinique Med Concorde
Laval, Quebec, H7G 2E6
Dr. Giovanni A. DiCostanzo
Markham, Ontario, L6B 1A1
Dr. Thu Van Nguyen
Montreal, Quebec, H2L 4M1
Dr. Pierre Karakiewicz
Montreal, Quebec, H2X 1N8
Dr. Morrie Liquornik
Newmarket, Ontario, L3X 1W1
Dr. Roger Buckley
North York, Ontario, M2J 1V1
Dr. Stanley Flax
North York, Ontario, M3B 3S6
Dr. Jack Barkin
North York, Ontario, M6A 3B5
Dr. Richard Casey
Oakville, Ontario, L6H 3P1
Orillia Urology Associates
Orillia, Ontario, L3V 7V1
Kawartha Urology Associates
Peterborough, Ontario, K9H 1T6
Dr. Mohamed Elharram
Peterborough, Ontario, K9J 7B3
Dr. Emmanuel Abara
Richmond Hill, Ontario, L4C 3X5
Dr. John Vary
Rimouski, Quebec, G5L 8W1
Dr. Vinod Mathur
Sault Ste. Marie, Ontario, P6A 2C3
Dr. Edward Woods
Scarborough Village, Ontario, M1P 2T7
Dr. Cal Andreou
Surrey, British Columbia, V3V 1N1
Dr. Nazif Omar
Surrey, British Columbia, V3V 1N1
Dr. Herman Kwan
Surrey, British Columbia, V4A 4N7
Dr. Nick Logarakis
Toronto, Ontario, M1P 2T7
Dr. Harold Kwok
Toronto, Ontario, M4X 1W4
Dr. Ashis Chawla
Toronto, Ontario, M6S 4W4
Dr. Jain Umesh
Toronto, Ontario, M6S 4W4
Dr. Thierry Tremblay
Val-d'Or, Quebec, J9P 3Y1
Westmount Med Bldg
Westmount, Quebec, H4A 1S9
About this study
Official title: A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.
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.
Read the detailed 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.
- Conditions
- Cancer of the Prostate
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the percentage of patients that will achieve a hormone refractory status at 3 years after initiation of Androgen Deprivation Treatment with Eligard®.
Measured: 3 Years
Secondary outcomes (3)
Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years.
Measured: 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®.
Measured: 3 years
Collect referral data if the patient was referred to a medical oncologist during treatment.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMX Research
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Hélène Grassin, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992251
- Sponsor's protocol ID
- LEUPR_L_04620
- Status last verified
- Dec 2016
- First submitted
- 7 Oct 2009
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.
- ClinicalTrials.gov ID
- NCT00992251
- Acronym / sponsor ID
- LEUPR_L_04620
- Conditions
- Cancer of the Prostate
- Keywords
- prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- CMX ResearchUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Aug 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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®.
Time frame: 3 Years
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Grassin study director
Sanofi
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Prostate, run by CMX Research at 36 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2016.