Clinical trial NCT01386684: Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study
Official title: Canadian Real-Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer (CRONOS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: JSS Medical Research Inc.
name: CMX Research
First posted: 2011-07-01
Enrollment: 552
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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 criteria: 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

Primary outcomes:
measure: Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0
timeFrame: 36 months
measure: Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests
timeFrame: 36 months
Secondary outcomes:
measure: Castration Resistant Prostate Cancer (CRPC): Number of Participants
timeFrame: 36 months
measure: Castration Resistant Prostate Cancer (CRPC): Time to Event
timeFrame: 36 months
measure: Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit
timeFrame: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
measure: Total Serum Testosterone Levels at Each Visit
timeFrame: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
measure: Total Serum Testosterone: Time to Increase Over Castrate Levels
timeFrame: 36 months
measure: Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit
timeFrame: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
measure: Prostatic Specific Antigen (PSA) Levels at Each Visit
timeFrame: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
measure: Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit
timeFrame: Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer
timeFrame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
measure: Treatment Compliance
timeFrame: Months 3, 6, 12, 18, 24, 30, and 36
measure: Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit.
timeFrame: Months 3, 6, 12, 18, 24, 30, and 36
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Corporation
name: Christina Pelizon, MD
role: STUDY_DIRECTOR
References: