PCa Patients Managed With ADT to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training

Study Overview
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Brief Summary
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The purpose of this observational study is to examine the level of activity in the prostate cancer population treated with Androgen Deprivation Therapy (ADT).

Detailed Description
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The aim of the current observational study will be to examine the level of activity in the prostate cancer population treated with ADT therapy; specifically, the impact of physical activity levels along with nutritional guidance through physician support. The application of an innovative technology to motivate patients will also be examined through the provision of an accelerometer/pedometer (NIKE+ FuelBand). The physical activity will be monitored by a NIKE+ Fuelband or tracked on an activity log.This study will assess the clinical and patient reported outcomes relevant to the management of their prostate cancer, in conjunction with a program assessing daily physical activities and nutritional guidance on the impact on the patient's quality of life, mobility and weight maintenance.

Official Title
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A Prospective, Single Arm Study in Prostate Cancer Patients Managed With Androgen Deprivation Therapy to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training (ELIFIT)

Conditions
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Cancer of the Prostate

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patient aged ≥ 18 years old Able to read and sign an approved Informed Consent Form (ICF) Diagnosed with locally advanced or metastatic prostate cancer Patient is treatment naive for ADT or has started ADT (3 or 4 month depot injection) AND has not received more than 1 treatment of 3 or 4 month ADT OR Patient is on intermittent therapy with an ADT agent and will be restarting ADT (3 or 4 month depot injection) ECOG (Eastern Cooperative Oncology Group) score of ≤ 2 Willingness to track weekly physical activities with or without participating in a home based exercise program during the course of this study. The physical activities will be tracked with a weekly activity log or a NIKE+ Fuelband Exclusion Criteria: Currently participating in a clinical study or observational study Has a survival expectancy of < 2 years Has any other condition that, in the opinion of the treating physician, may affect the patient's health or outcome of the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 EORTC QLQ-C30 | The EORTC QLQ-C30 is a questionnaire designed to measure quality of life of cancer patient. | Month 0 to Month 36 | 
| Changes in the patient quality of life (QoL) using the FACT-P | The FACT-P (Functional Assessment of Cancer Therapy - Prostate) is a questionnaire used to assess the health-related quality of life in men with prostate cancer. | Month 0 to Month 36 | 
| Changes in the patient quality of life (QoL) using the FACIT Fatigue Scale | The FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale is a questionnaire that measures an individuals level of fatigue during their usual daily activities over the past week. | Month 0 to Month 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine compliance of home-based exercises and regular physical activities | To determine the compliance of home-based exercises and regular physical activities using a weekly activity log. | 3 Years | 
| Determine the impact of exercise and physician support on activity levels | To determine the impact of exercise and physician support on activity levels using the weekly activity log, home diary or NIKE+ Fuelband. | 3 Years | 
| Assess the impact of nutritional guidance and exercise with physician support on BMI | To determine if BMI (body mass index) scores decrease with nutritional guidance and exercise with physician support. | 3 Years | 
| Mobility of prostate cancer patients measured by TUG Test | To assess the impact of nutritional guidance and exercise with physician support on the mobility of prostate cancer patients treated with ADT as measured by the Timed Up and Go Test (TUG) | 3 Years | 
| Determine the safety and tolerability of ADT in the management of prostate cancer | Safety and tolerability will be assessed based on the number and type of adverse events collected over the study duration. | 3 Years | 
| # of patients who discontinued prescribed treatment or intermittent usage of prescribed treatment | To determine # of patients who discontinued ADT therapy over the course of the study with reasons describing why. | 3 Years | 
| Mobility of prostate cancer patients measured by Five Times Sit to Stand Test (FTSST) | To assess the impact of nutritional guidance and exercise with physician support on the mobility of prostate cancer patients treated with ADT as measured by the Five Times Sit to Stand Test (FTSST). | 3 years |