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临床试验/NCT01386684
NCT01386684已完成不适用

Canadian Real-Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer (CRONOS)

AbbVie (prior sponsor, Abbott)0 个研究点目标入组 552 人开始时间: 2011年6月28日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
552
主要终点
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
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
Male
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

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

时间窗: 36 months

A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA \> 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

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

时间窗: 36 months

PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA \> 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

次要结局

  • Castration Resistant Prostate Cancer (CRPC): Number of Participants(36 months)
  • Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Total Serum Testosterone: Time to Increase Over Castrate Levels(36 months)
  • Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Castration Resistant Prostate Cancer (CRPC): Time to Event(36 months)
  • Total Serum Testosterone Levels at Each Visit(Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36)
  • Prostatic Specific Antigen (PSA) Levels at Each Visit(Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36)
  • Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • 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(Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36)
  • Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit(Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • 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(Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit.(Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Treatment Compliance(Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)
  • Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer(Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36)

研究者

发起方
AbbVie (prior sponsor, Abbott)
申办方类型
Industry
责任方
Sponsor

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