Carbohydrate Restriction and Prostate Cancer Growth (CAPS2)
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|ClinicalTrials.gov Identifier: NCT01763944|
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Behavioral: Low carbohydrate diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer|
|Actual Study Start Date :||December 16, 2013|
|Actual Primary Completion Date :||August 20, 2018|
|Actual Study Completion Date :||August 20, 2018|
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.
- PSA doubling time (change in PSA over time) [ Time Frame: Baseline, 3 and 6 months ]PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763944
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27702|
|Durham VA Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Pao-Hwa Lin||Duke University|