Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study

This study is currently recruiting participants.
Verified May 2013 by AbbVie
Sponsor:
Collaborators:
CMX Research
JSS Medical Research Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01386684
First received: June 30, 2011
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to evaluate the Canadian Real Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Duration of progression-free survival, defined as the time from patient recruitment to biochemical progression based on doubling of PSA (Prostate Specific Antigen) velocity or PSA > 5.0, objective tumor progression [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of refractory disease. [ Time Frame: at every visit for 36 months ] [ Designated as safety issue: No ]
  • Levels of total serum testosterone. [ Time Frame: at every visit for 36 months ] [ Designated as safety issue: No ]
  • Levels of serum PSA (Prostatic Specific Antigen) [ Time Frame: at every visit for 36 months ] [ Designated as safety issue: No ]
  • Patient Quality of Life [ Time Frame: at every visit for 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 550
Study Start Date: June 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prostate Cancer subjects
Prostate Cancer subjects

Detailed Description:

This is a Canadian Post Marketing Observational Study utilizing a prospective cohort design. Patients with Prostate Cancer who are prescribed Lupron will be entered into the study cohort and will be followed for a maximum of 36 months with recommended assessments at 3, 6, 12, 18, 24, 30 and 36 months after baseline. Treatment of the patients and follow up will be according to the physician's judgment, regional regulations and the product monograph

  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 will be enrolled from the offices of university or community urologists/oncologists across Canada treating patients with PCa.

Criteria

Inclusion Criteria:

i. Adult > 18 years old

ii. Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel

iii. Diagnosed with Prostate Cancer

iv. Prescribed Lupron as part of his treatment by his treating physician

Exclusion Criteria:

i. Currently participating in another prospective study including controlled clinical trials and observational studies.

• Exclusion of patient participating in other observational studies is necessary in order to prevent over-representation of specific patients in different studies, practical considerations regarding authority to utilize the patient's data and statistical issues related to lack of independence of the observations in different studies triggering multiplicity issues

ii. Patient cannot or will not sign informed consent

iii. Survival expectancy less than 2-3 years as per the treating physician's judgment

iv. Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of Prostate Cancer

v. History of alcohol or drug abuse

vi. No longer than 6 months of therapy if currently on luteinizing hormone-releasing hormone (LHRH) treatment

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386684

Contacts
Contact: Nabil Ackad 514 832-7439 nabil.ackad@abbvie.com
Contact: Suzanne Lemay 514-832-7494 suzanne.lemay@abbvie.com

Locations
Canada
Site Reference ID/Investigator# 56448 Recruiting
Abbottsford, Canada, V2S 3N6
Principal Investigator: Site Reference ID/Investigator# 56448            
Site Reference ID/Investigator# 56450 Recruiting
Barrie, Canada, L4M 7G1
Principal Investigator: Site Reference ID/Investigator# 56450            
Site Reference ID/Investigator# 54902 Active, not recruiting
Brampton, Canada, L6T 4S5
Site Reference ID/Investigator# 54543 Recruiting
Brantford, Canada, N8S 6T6
Principal Investigator: Site Reference ID/Investigator# 54543            
Site Reference ID/Investigator# 54904 Recruiting
Burlington, Canada, L7N 3V2
Principal Investigator: Site Reference ID/Investigator# 54904            
Site Reference ID/Investigator# 57123 Recruiting
Burlington, Canada, L7S 1V2
Principal Investigator: Site Reference ID/Investigator# 57123            
Site Reference ID/Investigator# 57032 Recruiting
Chicoutimi, Canada, G7H 4J1
Principal Investigator: Site Reference ID/Investigator# 57032            
Site Reference ID/Investigator# 55512 Active, not recruiting
Granby, Canada, J2G 8Z9
Site Reference ID/Investigator# 56447 Recruiting
Greenfield Park, Canada, J4V 2H3
Principal Investigator: Site Reference ID/Investigator# 56447            
Site Reference ID/Investigator# 56452 Recruiting
Guelph, Canada, N1H 5J1
Principal Investigator: Site Reference ID/Investigator# 56452            
Site Reference ID/Investigator# 89053 Recruiting
Halifax, Canada, B3H 1Y4
Principal Investigator: Site Reference ID/Investigator# 89053            
Site Reference ID/Investigator# 56446 Recruiting
Kelowna, Canada, V1Y 2H4
Principal Investigator: Site Reference ID/Investigator# 56446            
Site Reference ID/Investigator# 54903 Recruiting
Laval, Canada, H7G 2E6
Principal Investigator: Site Reference ID/Investigator# 54903            
Site Reference ID/Investigator# 54907 Recruiting
London, Canada, N6A 5W9
Principal Investigator: Site Reference ID/Investigator# 54907            
Site Reference ID/Investigator# 74493 Recruiting
Montreal, Canada, H3T 1E2
Principal Investigator: Site Reference ID/Investigator# 74493            
Site Reference ID/Investigator# 75313 Recruiting
Montreal, Canada, H2L 4M1
Principal Investigator: Site Reference ID/Investigator# 75313            
Site Reference ID/Investigator# 54909 Recruiting
Newmarket, Canada, L3X 1W1
Principal Investigator: Site Reference ID/Investigator# 54909            
Site Reference ID/Investigator# 54908 Recruiting
North York, Canada, M2J 1V1
Principal Investigator: Site Reference ID/Investigator# 54908            
Site Reference ID/Investigator# 54542 Recruiting
Oakville, Canada, L6H 3P1
Principal Investigator: Site Reference ID/Investigator# 54542            
Site Reference ID/Investigator# 61303 Recruiting
Oshawa, Canada, L1G 8A1
Principal Investigator: Site Reference ID/Investigator# 61303            
Site Reference ID/Investigator# 79774 Recruiting
Oshawa, Canada, L19 2B9
Principal Investigator: Site Reference ID/Investigator# 79774            
Site Reference ID/Investigator# 56449 Recruiting
Owensound, Canada, N4K 2J1
Principal Investigator: Site Reference ID/Investigator# 56449            
Site Reference ID/Investigator# 56917 Recruiting
Peterborough, Canada, K9H 1T6
Principal Investigator: Site Reference ID/Investigator# 56917            
Site Reference ID/Investigator# 61722 Recruiting
Peterborough, Canada, K9J 7B3
Principal Investigator: Site Reference ID/Investigator# 61722            
Site Reference ID/Investigator# 56445 Recruiting
Pointe-Claire, Canada, H9R 4S3
Principal Investigator: Site Reference ID/Investigator# 56445            
Site Reference ID/Investigator# 64145 Recruiting
Richmond Hill, Canada, L4C 3X5
Principal Investigator: Site Reference ID/Investigator# 64145            
Site Reference ID/Investigator# 54905 Active, not recruiting
Scarborough, Canada, M1S 4V5
Site Reference ID/Investigator# 54906 Recruiting
Scarborough, Canada, M1P 2T7
Principal Investigator: Site Reference ID/Investigator# 54906            
Site Reference ID/Investigator# 89633 Recruiting
St. John, Canada, E2L 3JB
Principal Investigator: Site Reference ID/Investigator# 89633            
Site Reference ID/Investigator# 56443 Completed
Surrey,, Canada, V3V 1N1
Site Reference ID/Investigator# 57762 Recruiting
Toronto, Canada, M1P 2T7
Principal Investigator: Site Reference ID/Investigator# 57762            
Site Reference ID/Investigator# 60843 Recruiting
Toronto, Canada, M4C 5M5
Principal Investigator: Site Reference ID/Investigator# 60843            
Site Reference ID/Investigator# 56444 Recruiting
Toronto, Canada, M6A 3B5
Principal Investigator: Site Reference ID/Investigator# 56444            
Site Reference ID/Investigator# 56451 Active, not recruiting
Toronto, Canada, M6S 4W4
Site Reference ID/Investigator# 56453 Recruiting
Trois-Rivieres, Canada, G9A 3V7
Principal Investigator: Site Reference ID/Investigator# 56453            
Site Reference ID/Investigator# 55513 Recruiting
Val d'Or, Canada, J9P 1W3
Principal Investigator: Site Reference ID/Investigator# 55513            
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
CMX Research
JSS Medical Research Inc.
Investigators
Study Director: Linda Assouline, PhD AbbVie Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01386684     History of Changes
Other Study ID Numbers: P12-811
Study First Received: June 30, 2011
Last Updated: May 2, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by AbbVie:
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 June 18, 2013