Carbohydrate Restriction and Prostate Cancer Growth (CAPS2)
No treatments have been shown to slow prostate cancer progression after radical prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer growth. A total of 60 men with a rising prostate-specific antigen (PSA) after failed primary treatment will be recruited and randomized to either a low-carbohydrate diet (<20 grams carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome is PSA doubling time.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer|
- PSA doubling time (change in PSA over time) [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Low carbohydrate, lifestyle counseling
The Low carbohydrate arm will receive counseling to follow a carbohydrate restriction diet (<20 grams per day) for 6 months.
Behavioral: Low carbohydrate diet
The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.
No Intervention: Control
The control arm will receive no dietary intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763944
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27702|
|Contact: Jordan Smith, RD 919-660-6719 firstname.lastname@example.org|
|Principal Investigator: Pao-Hwa Lin, PhD|
|Principal Investigator:||Pao-Hwa Lin||Duke University|