Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Study Overview
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Brief Summary
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This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI >25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.

Official Title
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Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Carbohydrate restricted diet
* Other: Non-restricted diet
* Other: Phone counseling with dietitian


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed prostate adenocarcinoma Most recent biopsy positive for prostate cancer Currently on or starting active surveillance Ability to read, write, and understand English BMI >24 kg/m2 Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer Age > 18 years Exclusion Criteria: Already consuming a severely carbohydrate-restricted (i.e. <20g total carbohydrates per day) or vegetarian diet Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study Anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy) Loss of >10% of body weight within the previous 6 months Currently receiving any oral hormonal therapy for prostate cancer or BPH (finasteride, dutasteride, bicalutamide) If prior oral hormonal therapy use for prostate cancer or BPH (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications) Having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (LHRH agonist, LHRH antagonists, ProstVax, Provenge) Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet. | Other: Carbohydrate restricted diet<br>* 20 grams total carbs/day<br>Other: Non-restricted diet<br>* Subject follows normal diet<br>Other: Phone counseling with dietitian<br>* Weekly calls with dietitian<br>|
| Experimental: Arm B<br>Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian | Other: Carbohydrate restricted diet<br>* 20 grams total carbs/day<br>Other: Non-restricted diet<br>* Subject follows normal diet<br>Other: Phone counseling with dietitian<br>* Weekly calls with dietitian<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference change in proliferative index in prostate cancer patients between carbohydrate restricted diet and non-restricted diet groups from pre-study biopsy (baseline) to 6 months. | Proliferative index is measured by Ki67/apoptosis rate | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in weight loss before and after intervention between between carbohydrate restricted diet and non-restricted diet groups from baseline to 6 months. |  | 6 months | 
| Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 6 months. | AUA intermediate risk is PSA > 10ng/ml or grade group ≥ 2 or clinical stage ≥ T2b | 6 months | 
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using EORTC-QLQ-C30. |  | 6 months | 
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IPSS. |  | 6 months | 
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACT-Cog. |  | 6 months | 
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using PROMIS-fatigue. |  | 6 months | 
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACIT-F. |  | 6 months | 
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IIEF-5. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Prostate Adenocarcinoma, Active Surveillance, Weight Loss, low carb, Ketogenic Diet, Ketogenic, Diet