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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

552 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-28

Study Completion Date

2016-09-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Cancer

Keywords

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Prostate Cancer

Patients with prostate cancer who were receiving treatment with leuprolide acetate (Lupron).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel
* Diagnosed with Prostate Cancer
* Prescribed Lupron as part of his treatment by his treating physician

Exclusion Criteria

* Currently participating in another prospective study including controlled clinical trials and observational studies.
* Patient cannot or will not sign informed consent
* Survival expectancy less than 2-3 years as per the treating physician's judgment
* 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
* History of alcohol or drug abuse
* No longer than 6 months of therapy if currently on luteinizing hormone-releasing hormone (LHRH) treatment

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Pelizon, MD

Role: STUDY_DIRECTOR

AbbVie Corporation

Countries

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Canada

Other Identifiers

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P12-811

Identifier Type: -

Identifier Source: org_study_id