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

This study is ongoing, but not recruiting participants.
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: April 7, 2014
Last verified: April 2014
  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: July 2016
Estimated Primary Completion Date: July 2016 (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. Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel

ii. Diagnosed with Prostate Cancer

iii. 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

Locations
Canada
Site Reference ID/Investigator# 56448
Abbottsford, Canada, V2S 3N5
Site Reference ID/Investigator# 56450
Barrie, Canada, L4M 7G1
Site Reference ID/Investigator# 54902
Brampton, Canada, L6T 4S5
Site Reference ID/Investigator# 54543
Brantford, Canada, N8S 6T6
Site Reference ID/Investigator# 54904
Burlington, Canada, L7N 3V2
Site Reference ID/Investigator# 57123
Burlington, Canada, L7S 1V2
Site Reference ID/Investigator# 57032
Chicoutimi, Canada, G7H 4J1
Site Reference ID/Investigator# 55512
Granby, Canada, J2G 8Z9
Site Reference ID/Investigator# 56447
Greenfield Park, Canada, J4V 2H3
Site Reference ID/Investigator# 56452
Guelph, Canada, N1H 5J1
Site Reference ID/Investigator# 89053
Halifax, Canada, B3H 1Y4
Site Reference ID/Investigator# 56446
Kelowna, Canada, V1W 4V5
Site Reference ID/Investigator# 54903
Laval, Canada, H7G 2E6
Site Reference ID/Investigator# 54907
London, Canada, N6A 5W9
Site Reference ID/Investigator# 74493
Montreal, Canada, H3T 1E2
Site Reference ID/Investigator# 75313
Montreal, Canada, H2L 4M1
Site Reference ID/Investigator# 54909
Newmarket, Canada, L3X 1W1
Site Reference ID/Investigator# 54908
North York, Canada, M2J 1V1
Site Reference ID/Investigator# 54542
Oakville, Canada, L6H 3P1
Site Reference ID/Investigator# 61303
Oshawa, Canada, L1G 8A1
Site Reference ID/Investigator# 79774
Oshawa, Canada, L19 2B9
Site Reference ID/Investigator# 56449
Owensound, Canada, N4K 2J1
Site Reference ID/Investigator# 61722
Peterborough, Canada, K9J 7B3
Site Reference ID/Investigator# 56917
Peterborough, Canada, K9H 1T6
Site Reference ID/Investigator# 56445
Pointe-Claire, Canada, H9R 4S3
Site Reference ID/Investigator# 64145
Richmond Hill, Canada, L4C 3X5
Site Reference ID/Investigator# 54906
Scarborough, Canada, M1P 2T7
Site Reference ID/Investigator# 54905
Scarborough, Canada, M1S 4V5
Site Reference ID/Investigator# 89633
St. John, Canada, E2L 3JB
Site Reference ID/Investigator# 56443
Surrey,, Canada, V3V 1N1
Site Reference ID/Investigator# 56444
Toronto, Canada, M6A 3B5
Site Reference ID/Investigator# 56451
Toronto, Canada, M6S 4W4
Site Reference ID/Investigator# 60843
Toronto, Canada, M4C 5M5
Site Reference ID/Investigator# 57762
Toronto, Canada, M1P 2T7
Site Reference ID/Investigator# 56453
Trois-Rivieres, Canada, G9A 3V7
Site Reference ID/Investigator# 55513
Val d'Or, Canada, J9P 1W3
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: April 7, 2014
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 April 15, 2014