Improving Energy Balance in Men With Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and energy balance may play a major role in prostate cancer progression. PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy energy-restricted diet and exercise, in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.

Detailed Description
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This is a 2-arm randomized controlled feasibility trial among 40 overweight or obese men newly diagnosed with prostate cancer who are scheduled for prostatectomy. This study will use the presurgical period to explore the potential impact of weight loss via a healthy energy-restricted diet and increased physical activity on circulating hormones, cytokines, and growth factors, as well as effects on tumor biology and other clinical outcomes. Consenting patients will be block randomized to 1-of-2 study arms: 1) a healthful diet + exercise intervention to promote a weight loss of up to 2 pounds/week; or 2) a wait-list control who will receive the intervention once the study period is complete. Both groups will receive nutritional counseling during the study period to correct nutritional deficiencies with food sources. This study will explore and contrast changes in body mass index (BMI) observed over the study period (minimum of 3.5 weeks) in the intervention vs. wait-list control arms, and also monitor changes in body composition, energy intake and physical activity; these changes will be studied in relation to the following endpoints: a) changes in select circulating biomarkers and gene expression related to cancer progression, hormonal status, inflammation and other energy-related factors; b) rates of tumor proliferation and apoptosis; c) tumor immunohistochemical markers of insulin receptor, vascular endothelial growth factor (VEGF), AKT, and nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB); and d) functional and health-related outcomes, i.e., side-effects and medical outcomes, quality of life (QoL), and functional status.

Official Title
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Exploring the Impact of Negative Energy Balance in Men With Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Immediate diet and exercise intervention
* Behavioral: Delayed diet and exercise intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathologically confirmed prostate cancer Elects prostatectomy as first line treatment (i.e., no androgen ablation, radiation therapy, etc) Has at least 3.5 weeks lag-time until scheduled prostatectomy (must be able to participate in the diet and exercise program a full 3.5 weeks). Body mass index (BMI) 25 - 49.9 Mentally competent Able to speak and write English Has telephone access Agrees to be randomized to either study arm (immediate or delayed diet and exercise program) Exclusion Criteria: Another active malignancy (not including non-melanoma skin cancer) Medical conditions that affect weight (e.g., untreated thyroid disturbances Currently on a weight loss regimen Preexisting medical condition(s) that preclude adherence to unsupervised exercise, e.g., severe orthopedic conditions, scheduled for a hip or knee replacement, bone metastases, paralysis, dementia, untreated stage 3 hypertension, or unstable angina, heart attack, congestive heart failure or conditions that dictated hospitalization or oxygen within 6-mths, etc.

Ages Eligible for Study
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Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate diet and exercise intervention<br>A healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week | Behavioral: Immediate diet and exercise intervention<br>* Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).<br>|
| Other: Delayed diet and exercise intervention<br>This arm will receive the same diet and exercise intervention as the experimental arm once recovery from prostatectomy is achieved. | Behavioral: Delayed diet and exercise intervention<br>* Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Proliferation Rate (Ki-67) | Changes in tumor proliferation rate (Ki-67) over the presurgical study period (minimum of 3.5 weeks, up to 24 weeks) will be explored and compared between the intervention and wait-list control arms. | Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight and composition, energy intake and physical activity | Changes in body composition, energy intake and physical activity over the presurgical study period (minimum of 3.5 weeks, up to 24 weeks) will be explored and compared between the intervention and wait-list control arms. | Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, intervention, diet, physical activity, exercise, weight loss, biomarkers, cancer progression