Prostate CancerNCT01386684
Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study
An observational study of Prostate Cancer, run by AbbVie (prior sponsor, Abbott).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 552 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2011to 8 Sep 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled from the offices of university or community urologists/oncologists across Canada treating patients with PCa.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Canadian Real-Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer (CRONOS)
The purpose of this study is to evaluate the Canadian Real Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer.
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Prostate Cancer | Patients with prostate cancer who were receiving treatment with leuprolide acetate (Lupron). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 36 months
Secondary outcomes (34)
Castration Resistant Prostate Cancer (CRPC): Number of Participants
CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests.
Measured: 36 months
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.
Measured: 36 months
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.
Measured: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Total Serum Testosterone Levels at Each Visit
Total serum testosterone was assessed at each study visit.
Measured: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
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.
Measured: 36 months
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.
Measured: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Prostatic Specific Antigen (PSA) Levels at Each Visit
Serum PSA was assessed at each study visit.
Measured: 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
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.
Measured: Month 0 (Baseline) and Months 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 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.
Measured: 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
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.
Measured: 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 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 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.
Measured: 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
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.
Measured: 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
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.
Measured: Month 0 (Baseline) and 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
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.
Measured: 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
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.
Measured: Month 0 (Baseline) and 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Treatment Compliance
Treatment compliance by participants was assessed as the number of missed injections since the last visit.
Measured: Months 3, 6, 12, 18, 24, 30, and 36
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.
Measured: Months 3, 6, 12, 18, 24, 30, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study start28 Jun 2011
- Primary completion8 Sep 2016
- Study completion8 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc., CMX Research
- Responsible party
- Sponsor
- Investigators
- Christina Pelizon, MD, Study director, AbbVie Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386684
- Sponsor's protocol ID
- P12-811
- Status last verified
- Aug 2017
- First submitted
- 30 Jun 2011
- Last updated
- 13 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Real-Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer (CRONOS)
- ClinicalTrials.gov ID
- NCT01386684
- Acronym / sponsor ID
- P12-811
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc., CMX Research
- Study start
- 28 Jun 2011 (actual)
- Primary completion
- 8 Sep 2016 (actual)
- Study completion
- 8 Sep 2016 (actual)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Posted 2 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Prostate Cancer | – | –Patients with prostate cancer who were receiving treatment with leuprolide acetate (Lupron). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled from the offices of university or community urologists/oncologists across Canada treating patients with PCa.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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
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.
34 secondary outcomes
Castration Resistant Prostate Cancer (CRPC): Number of Participants
Time frame: 36 months
Castration Resistant Prostate Cancer (CRPC): Time to Event
Time frame: 36 months
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
Total Serum Testosterone Levels at Each Visit
Time frame: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Total Serum Testosterone: Time to Increase Over Castrate Levels
Time frame: 36 months
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
Prostatic Specific Antigen (PSA) Levels at Each Visit
Time frame: 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
Time frame: Month 0 (Baseline) and Months 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
Time frame: 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
Time frame: 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
Time frame: 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 Physician for Prostate Cancer
Time frame: 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
Time frame: 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 Healthcare Professional for Prostate Cancer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 an Ambulance Service for Prostate Cancer
Time frame: 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
Time frame: 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
Time frame: Month 0 (Baseline) and 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
Time frame: 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
Time frame: Month 0 (Baseline) and 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Treatment Compliance
Time frame: Months 3, 6, 12, 18, 24, 30, and 36
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit.
Time frame: Months 3, 6, 12, 18, 24, 30, and 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Pelizon, MD study director
AbbVie Corporation
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.