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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386684
• Other study ID #: P12-811
• Status: Completed
• Start date: June 28, 2011
• Est. completion date: September 8, 2016

Study information

• Verified date: August 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: September 8, 2016
• Est. primary completion date: September 8, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	CMX Research, JSS Medical Research Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	36 months
Primary	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	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.	36 months
Secondary	Castration Resistant Prostate Cancer (CRPC): Number of Participants	CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests.	36 months
Secondary	Castration Resistant Prostate Cancer (CRPC): Time to Event	CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided.	36 months
Secondary	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	Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone = 0.7 nmol/L, > 0.7 to = 1.7 nmol/L, and > 1.7 nmol/L are provided at each time point.	Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Secondary	Total Serum Testosterone Levels at Each Visit	Total serum testosterone was assessed at each study visit.	Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Secondary	Total Serum Testosterone: Time to Increase Over Castrate Levels	Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.	36 months
Secondary	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	Serum PSA was assessed at each study visit. The percentage of participants with serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and =10 ng/mL are provided at each time point.	Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Secondary	Prostatic Specific Antigen (PSA) Levels at Each Visit	Serum PSA was assessed at each study visit.	Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Secondary	Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit	The FACT-G questionnaire is used with patients of any tumor type to assess patient quality of life (QoL). FACT-G is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-G was analyzed using repeated measures mixed effects general linear model (GLM). A positive change from baseline indicates improved QoL.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit	The FACT-P questionnaire is used with patients with prostate cancer to assess patient quality of life (QoL). FACT-P is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-P use a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). The FACT-P total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-P was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates decreased QoL.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit	IIEF-5 is a 5-item, self-administered questionnaire assessing the presence and severity of erectile dysfunction. A score of 1 (very low) to 5 (very high) is awarded to each of the 5 questions. The IIEF-5 total score is a sum of the responses to the 5 items. Total scores range from 5 to 25, with higher scores indicating less dysfunction. Change in IIEF-5 was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates an increase in dysfunction.	Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer	The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.	Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Treatment Compliance	Treatment compliance by participants was assessed as the number of missed injections since the last visit.	Months 3, 6, 12, 18, 24, 30, and 36
Secondary	Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit.	Participants were asked "Have there been any changes in the current prostate cancer treatment (not including Lupron) since last visit?"; if Yes, was the change "Initiation of new mediation/Change in Dose/Frequency" or "Discontinuation of medication". The percentage of subjects at each visit with a change in current prostate cancer treatment (Initiation or Change in Dose/Frequency or Discontinuation of Medication) is presented.	Months 3, 6, 12, 18, 24, 30, and 36

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