Evaluation of Diet and Exercise in Prostate Cancer Patients

Study Overview
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Brief Summary
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Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed with Lupron.

Detailed Description
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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.

Official Title
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Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed With Lupron (CRONOS II)

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate Cancer Patients<br>Prostate Cancer Patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36) | 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. | From Month 0 to Month 18 | 
| Change in exercise duration | Assessed at every visit what was the amount of various types of exercise performed in the previous month. | From Month 0 to Month 18 | 
| Change in dietary habits | 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. | From Month 0 to Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36) | 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. | From Month 0 to follow-up visits 3,6 and 12 months | 
| Change in weight | Change from Baseline is calculated as the post-Baseline value minus the Baseline value. | From Month 0 to Month 18 | 
| Change in Body Mass Index (BMI) | 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. | From Month 0 to Month 18 | 
| Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI) | 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. | From Month 0 to Month 18 | 
| Changes in the sexual function using the International Index of Erectile Function (IIEF-5) | An abridged 5 item self-administered questionnaire assessing the presence and severity of erectile dysfunction (for patients enrolled prior to protocol amendment 2) | From Month 0 to Month 18 | 
| Number of patients with Adverse Events | 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 | From Month 0 to Month 18 | 
| Changes in the patient's medical condition | Any change in the patient's medical condition including new onset or worsening of medical conditions. | From Month 0 to Month 18 | 
| Proportion of patients with castrate levels of testosterone and undetectable levels of Prostatic Specific Antigen (PSA) at 18 months of treatments. | 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. | From Month 0 to Month 18 | 
| Leuprolide Acetate Utilization | Utilization of Leuprolide Acetate will be assessed. | From Month 0 to Month 18 | 
| Changes in the Doctor-Patient communication (for patients enrolled prior to protocol amendment 2) | 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 | From Month 0 to Month 18 | 
| Caregiver Quality of Life (for patients enrolled under protocol amendment 1) | 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. | From Month 0 to Month 18 | 
| Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1) | Measured with a self-reported questionnaire. | Up to Month 18 | 
| Lupron Cares Patient Support Program | Enrollment and use will be assessed for the patient support program. | Up to Month 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer