N/A
Completed N=552
Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study
Source: ClinicalTrials.gov NCT01386684 ↗Enrolled (actual)
552
Serious AEs
23.9%
Results posted
Apr 2018
Primary outcomePrimary: 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 — 20.76 months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
20.76 | — |
| 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 |
21.89 | — |
| SECONDARY Castration Resistant Prostate Cancer (CRPC): Number of Participants |
84 | — |
| SECONDARY Castration Resistant Prostate Cancer (CRPC): Time to Event |
26.01 | — |
| 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 |
16.3; 65.3; 62.9; 68.8; 69.0; 68.8 | — |
| SECONDARY Total Serum Testosterone Levels at Each Visit |
10.9; 0.6; 1.0; 1.5; 1.9; 2.1 | — |
| SECONDARY Total Serum Testosterone: Time to Increase Over Castrate Levels |
31.20 | — |
| 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 |
15.2; 55.9; 61.8; 63.6; 64.6; 60.7 | — |
| SECONDARY Prostatic Specific Antigen (PSA) Levels at Each Visit |
65.0; 6.5; 12.0; 19.1; 13.3; 11.2 | — |
| SECONDARY Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit |
-0.9; -2.2; -1.7; -1.0; -1.4; -1.3 | — |
| SECONDARY Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit |
-1.1; -2.8; -2.4; -1.8; -2.1; -2.3 | — |
| SECONDARY International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit |
-2.7; -3.2; -3.3; -3.7; -3.5; -3.3 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications |
452; 408; 384; 328; 279; 258 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer |
38; 44; 38; 34; 20; 23 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer |
1.2; 1.5; 7.1; 1.6; 2.7; 2.4 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer |
20; 23; 20; 21; 8; 11 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer |
7.8; 3.5; 18.5; 3.1; 2.3; 1.7 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer |
9; 7; 3; 8; 5; 6 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer |
1.2; 1.0; 1.0; 1.4; 1.0; 1.0 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer |
4; 2; 4; 2; 2; 3 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer |
1.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer |
3; 2; 1; 4; 3; 0 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer |
1.0; 1.0; 3.5 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer |
9; 8; 12; 9; 5; 6 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer |
7.4; 2.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer |
29; 14; 9; 14; 9; 5 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer |
1.0; 1.0; 1.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer |
21.5; 19.3; 25.5; 26.6; 20.9; 13.9 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer |
0.9; 2.5; 2.5; 0.8; 2.4; 2.6 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer |
14.0; 2.6; 4.1; 3.0; 2.7; 6.8 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer |
14.0; 2.6; 4.1; 3.0; 2.7; 6.8 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer |
4.0; 7.5; 21.0; 7.3; 2.1; 2.4 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer |
4.9; 4.9; 14.7; 28.9; 0.4; 1.4 | — |
| SECONDARY Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer |
20.0; 19.5; 23.0; 9.2; 6.3; 10.6 | — |
| SECONDARY Treatment Compliance |
0.0; 0.0; 0.1; 0.2; 0.2; 0.2 | — |
| SECONDARY Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. |
9.4; 90.6; 42.6; 57.4; 54.1; 45.9 | — |
Eligibility Criteria
Inclusion Criteria
- Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel
- Diagnosed with Prostate Cancer
- Prescribed Lupron as part of his treatment by his treating physician
Exclusion Criteria
- Currently participating in another prospective study including controlled clinical trials and observational studies.
- Patient cannot or will not sign informed consent
- Survival expectancy less than 2-3 years as per the treating physician's judgment
- Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of Prostate Cancer
- History of alcohol or drug abuse
- No longer than 6 months of therapy if currently on luteinizing hormone-releasing hormone (LHRH) treatment
Data sourced from ClinicalTrials.gov (NCT01386684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.