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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Phase: N/A

Status: Active, not recruiting

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Linda Assouline, PhD, Study Director, Affiliation: AbbVie Corporation

Summary

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

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: 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

Secondary outcome:

Incidence of refractory disease.

Levels of total serum testosterone.

Levels of serum PSA (Prostatic Specific Antigen)

Patient Quality of Life

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Site Reference ID/Investigator# 56448, Abbottsford V2S 3N5, Canada

Site Reference ID/Investigator# 56450, Barrie L4M 7G1, Canada

Site Reference ID/Investigator# 54902, Brampton L6T 4S5, Canada

Site Reference ID/Investigator# 54543, Brantford N8S 6T6, Canada

Site Reference ID/Investigator# 54904, Burlington L7N 3V2, Canada

Site Reference ID/Investigator# 57123, Burlington L7S 1V2, Canada

Site Reference ID/Investigator# 57032, Chicoutimi G7H 4J1, Canada

Site Reference ID/Investigator# 55512, Granby J2G 8Z9, Canada

Site Reference ID/Investigator# 56447, Greenfield Park J4V 2H3, Canada

Site Reference ID/Investigator# 56452, Guelph N1H 5J1, Canada

Site Reference ID/Investigator# 89053, Halifax B3H 1Y4, Canada

Site Reference ID/Investigator# 56446, Kelowna V1W 4V5, Canada

Site Reference ID/Investigator# 54903, Laval H7G 2E6, Canada

Site Reference ID/Investigator# 54907, London N6A 5W9, Canada

Site Reference ID/Investigator# 74493, Montreal H3T 1E2, Canada

Site Reference ID/Investigator# 75313, Montreal H2L 4M1, Canada

Site Reference ID/Investigator# 54909, Newmarket L3X 1W1, Canada

Site Reference ID/Investigator# 54908, North York M2J 1V1, Canada

Site Reference ID/Investigator# 54542, Oakville L6H 3P1, Canada

Site Reference ID/Investigator# 61303, Oshawa L1G 8A1, Canada

Site Reference ID/Investigator# 79774, Oshawa L19 2B9, Canada

Site Reference ID/Investigator# 56449, Owensound N4K 2J1, Canada

Site Reference ID/Investigator# 56917, Peterborough K9H 1T6, Canada

Site Reference ID/Investigator# 61722, Peterborough K9J 7B3, Canada

Site Reference ID/Investigator# 56445, Pointe-Claire H9R 4S3, Canada

Site Reference ID/Investigator# 64145, Richmond Hill L4C 3X5, Canada

Site Reference ID/Investigator# 54905, Scarborough M1S 4V5, Canada

Site Reference ID/Investigator# 54906, Scarborough M1P 2T7, Canada

Site Reference ID/Investigator# 89633, St. John E2L 3JB, Canada

Site Reference ID/Investigator# 56443, Surrey, V3V 1N1, Canada

Site Reference ID/Investigator# 56444, Toronto M6A 3B5, Canada

Site Reference ID/Investigator# 56451, Toronto M6S 4W4, Canada

Site Reference ID/Investigator# 57762, Toronto M1P 2T7, Canada

Site Reference ID/Investigator# 60843, Toronto M4C 5M5, Canada

Site Reference ID/Investigator# 56453, Trois-Rivieres G9A 3V7, Canada

Site Reference ID/Investigator# 55513, Val d'Or J9P 1W3, Canada

Additional Information

Starting date: June 2011
Last updated: August 6, 2015

Page last updated: August 23, 2015

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