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

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Linda Assouline, PhD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie Corporation


Canada: Ethics Review Committee

Study ID:




Start Date:

June 2011

Completion Date:

May 2017

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms