NCT03679260

Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Carbohydrate restricted diet	20 grams total carbs/day
OTHER	Non-restricted diet	Subject follows normal diet
OTHER	Phone counseling with dietitian	Weekly calls with dietitian

Timeline

• Start date: 2018-09-25
• Primary completion: 2023-03-24
• Completion: 2023-03-24
• First posted: 2018-09-20
• Last updated: 2023-03-30

Locations

1 site across 1 country: United States