Energy Balance for Prostate Cancer Survivorship

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.

Detailed Description
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The weight management program is designed to help participants lose weight before their prostatectomy and to help them maintain that weight loss after surgery. There are four main components to the weight management program. The four components of the program are: Diet Physical activity Coaching Diet and exercise monitoring tool The program will be tailored to each individual participant. All participants will be ask to monitor their program using a tool provided by the study team. Participants will be actively participating in the study activities for about 5 months. After that, the study team will review medical records for up to 10 years after enrollment to monitor weight changes and cancer status.

Official Title
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Energy Balance for Prostate Cancer Survivorship

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Weight Loss Program
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2) Body Mass Index (BMI) 25-45 kg/m2 Have internet access Have an iPad/iPhone/iDevice Exclusion Criteria: History of 5 alpha reductase inhibitors prior 3 months History of radiation therapy Taking active cancer treatment Undergoing salvage therapy Castration-resistant prostate cancer Evidence of metastasis Evidence of biochemical recurrence High risk medical condition (e.g. gout or kidney disease)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 72 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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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight loss intervention Group<br>Participants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience. | Other: Weight Loss Program<br>* Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.<br>|
| Active Comparator: Comparison Group<br>All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm. | Other: Standard of Care<br>* Standard of Care for this patient population.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight during the post-surgical period |  | Change from Surgery to Week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight during the pre-surgical weight-loss intervention |  | Change from Baseline to Week 8 | 
| Changes in diet quality during the pre-surgical weight-loss intervention | Changes will be measured by analyzing results from alternative healthy eating index scores. | Change from Baseline to Week 8 | 
| Prostate cancer status | Evidence of recurrence of cancer | Week 20 | 
| Change in cardiovascular biomarkers | Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose. | Change from Baseline to Week 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, prostatectomy, weight loss, prevent weight gain