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Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT01386684 (opens ClinicalTrials.gov in a new tab)Other idP12-811
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Leuprolide, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase not stated
Enrollment
552 participants (actual)
Sponsor
AbbVie (prior sponsor, Abbott) · Industry
Design
Not stated
Countries
Not stated
Start
28 Jun 2011
Primary completion
8 Sept 2016
Completion
8 Sept 2016
First posted
1 Jul 2011 (estimated)
Last update posted
13 Dec 2018
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014201520162017
  1. Ph –

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

    NCT01386684

    28 Jun 2011 to 8 Sept 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Arms1

  • Other

    Patients with Prostate Cancer

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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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

    Time frame · 36 months

    Registry description

    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.

  2. 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

    Time frame · 36 months

    Registry description

    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.

Secondary outcomes(20)

  1. Castration Resistant Prostate Cancer (CRPC): Number of Participants

    Time frame · 36 months

    Registry description

    CRPC defined as PSA \> 2 ng/mL on at least 2 consecutive tests.

  2. Castration Resistant Prostate Cancer (CRPC): Time to Event

    Time frame · 36 months

    Registry description

    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.

  3. 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

    Time frame · Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  4. Total Serum Testosterone Levels at Each Visit

    Time frame · Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

    Registry description

    Total serum testosterone was assessed at each study visit.

  5. Total Serum Testosterone: Time to Increase Over Castrate Levels

    Time frame · 36 months

    Registry description

    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.

  6. 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

    Time frame · Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  7. Prostatic Specific Antigen (PSA) Levels at Each Visit

    Time frame · Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

    Registry description

    Serum PSA was assessed at each study visit.

  8. Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  9. Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  10. International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit

    Time frame · Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  11. Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  12. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  13. Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  14. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  15. Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  16. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  17. Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  18. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  19. Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

  20. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer

    Time frame · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 36 months

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

GroupValue (months)Spread
Patients With Prostate Cancer20.760.59
Primary outcomeMean· 36 months

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

GroupValue (months)Spread
Patients With Prostate Cancer21.890.69
Secondary and other outcome results(6)
Secondary outcomeNumber· 36 months

Castration Resistant Prostate Cancer (CRPC): Number of Participants

GroupValue (participants)
Patients With Prostate Cancer84
Secondary outcomeMean· 36 months

Castration Resistant Prostate Cancer (CRPC): Time to Event

GroupValue (months)Spread
Patients With Prostate Cancer26.010.42
Secondary outcomeNumber· Months 0 (Baseline), 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

GroupValue (percentage of participants)
Patients With Prostate Cancer16.3
Secondary outcomeMean· Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

Total Serum Testosterone Levels at Each Visit

GroupValue (nmol/L)Spread
Patients With Prostate Cancer10.98.90
Secondary outcomeMean· 36 months

Total Serum Testosterone: Time to Increase Over Castrate Levels

GroupValue (months)Spread
Patients With Prostate Cancer31.200.67
Secondary outcomeNumber· Months 0 (Baseline), 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

GroupValue (percentage of participants)
Patients With Prostate Cancer15.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Patients With Prostate CancerPatients with prostate cancer who were receiving treatment with Lupron.–132 / 55277 / 552

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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