Prostate Cancer
Conditions
Keywords
Prostate cancer
Brief summary
Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed with Lupron.
Detailed description
This is a study utilizing a prospective cohort design. Patients with Prostrate cancer (PCa) who are prescribed Lupron will be entered into the study cohort and will be followed for a maximum of 18 months with recommended assessments at 3, 6, 12 and 18 months after Day 1. Treatment of the patients and follow up will be according to the physicians' judgment, regional regulations and the product monograph.
Interventions
None listed
Sponsors
JSS Medical Research; CMX Research Inc.; Canadian Urology Research Consortium
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
i. Adult ≥ 18 years old ii. Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel. iii. Diagnosed with PCa. iv. Prescribed Lupron as part of his treatment by his treating physician.
Exclusion criteria
i. Patient cannot or will not sign informed consent. ii. 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 PCa. iii. More than 6 months of therapy if currently on continuous Luteinizing hormone-releasing hormone (LHRH) treatment. iv. If at study enrollment the intent is to only prescribe 1 dose of Lupron (leuprolide acetate)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36) | From Month 0 to Month 18 | The SF-36 Health is a 36-item general health self-administered questionnaire consisting of 8 scales measuring Physical Function, Physical Role limitations, Vitality, General Health, Pain, Social Function, Emotional Role limitations, and Mental Health. |
| Change in exercise duration | From Month 0 to Month 18 | Assessed at every visit what was the amount of various types of exercise performed in the previous month. |
| Change in dietary habits | From Month 0 to Month 18 | Assessed at every visit to what extent patient's complied with the Canadian Food Guide's recommendation for each of the four food group servings in the previous week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI) | From Month 0 to Month 18 | A validated questionnaire designed to measure quality of life in patients with prostate cancer. It consists of 20 questions that assess urinary, sexual, bowel and hormonal function and impairment in patients with prostate cancer. |
| Changes in the sexual function using the International Index of Erectile Function (IIEF-5) | From Month 0 to Month 18 | An abridged 5 item self-administered questionnaire assessing the presence and severity of erectile dysfunction (for patients enrolled prior to protocol amendment 2) |
| Number of patients with Adverse Events | From Month 0 to Month 18 | Adverse events which lead to discontinuation of prescribed treatment under observation, will be coded according to the Medical Dictionary for Regulatory Activities (MeDRA) dictionary of terms |
| Changes in the patient's medical condition | From Month 0 to Month 18 | Any change in the patient's medical condition including new onset or worsening of medical conditions. |
| Proportion of patients with castrate levels of testosterone and undetectable levels of Prostatic Specific Antigen (PSA) at 18 months of treatments. | From Month 0 to Month 18 | The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. A testosterone test checks the level of this male hormone (androgen) in the blood. |
| Change in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36) | From Month 0 to follow-up visits 3,6 and 12 months | The SF-36 Health is a 36-item general health self-administered questionnaire consisting of 8 scales measuring Physical Function, Physical Role limitations, Vitality, General Health, Pain, Social Function, Emotional Role limitations, and Mental Health. |
| Changes in the Doctor-Patient communication (for patients enrolled prior to protocol amendment 2) | From Month 0 to Month 18 | This will be ascertained with the Doctor-Patient Communication/Doctor's Questionnaire and the Doctor-Patient Communication/Patient's Questionnaire that are validated questionnaires developed by the College of Physicians of Quebec |
| Caregiver Quality of Life (for patients enrolled under protocol amendment 1) | From Month 0 to Month 18 | Measured with the Caregiver Quality of Life Index - Cancer scale (CQOLC). This is a 35 item questionnaire that measures the quality of life of individuals caring for cancer patients. |
| Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1) | Up to Month 18 | Measured with a self-reported questionnaire. |
| Lupron Cares Patient Support Program | Up to Month 18 | Enrollment and use will be assessed for the patient support program. |
| Leuprolide Acetate Utilization | From Month 0 to Month 18 | Utilization of Leuprolide Acetate will be assessed. |
| Change in weight | From Month 0 to Month 18 | Change from Baseline is calculated as the post-Baseline value minus the Baseline value. |
| Change in Body Mass Index (BMI) | From Month 0 to Month 18 | BMI is a measure of body fat based on weight in relation to height. Change from Baseline is calculated as the post-Baseline value minus the Baseline value. |
Countries
Canada
Outcome results
None listed