Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy

Study Overview
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Brief Summary
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The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer.

Official Title
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Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy

Conditions
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Obesity, Prostate Cancer

Intervention / Treatment
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* Behavioral: Weight Loss Program
* Behavioral: Standardized educational flyer
* Behavioral: Weight Maintenance Program


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

Ages Eligible for Study
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Minimum Age: 50 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Loss and Weight Maintenance<br>Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery. | Behavioral: Weight Loss Program<br>* Program involves one-on-one coaching, diet meal plan, and physical activity plan.<br>Behavioral: Weight Maintenance Program<br>* Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.<br>|
| Active Comparator: Control<br>Participants will receive a standardized educational flyer about a healthy diet and exercise. | Behavioral: Standardized educational flyer<br>* The American Institute for Cancer Research handout Nutrition and the Cancer Survivor will be provided to participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of weight loss before and weight maintenance after Prostate Cancer (PCa) surgery on immunosuppressive factors | Impact will be measured by changes in specific blood immune biomarker biomarkers. | Change from Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of weight loss before and weight maintenance after PCa surgery on inflammation factors | Impact will be measured by changes in specific blood inflammation biomarkers. | Change from Baseline to Month 6 | 
| Change in weight |  | Change from Baseline to Month 6 | 
| Change in body composition | Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA). | Change from Baseline to Prior to Surgery, from 4 to 16 weeks | 
| Change in Quality of Life | Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life. | Change from Baseline to Month 6 |