- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01763944
Carbohydrate Restriction and Prostate Cancer Growth (CAPS2)
October 10, 2018 updated by: Duke University
A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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North Carolina
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Durham, North Carolina, United States, 27705
- Durham VA Medical Center
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Durham, North Carolina, United States, 27702
- Duke University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Received prior radical prostatectomy or definitive local radiation for prostate cancer (either external beam radiation, brachytherapy, or combination)
- PSA within the past 3 months is between 0.4 and 20 if prior radical prostatectomy, or between 3 and 20 ng/ml if prior radiation therapy.
PSA doubling time (PSADT) >3 months and <36 months
- Calculated based at least 2 values (at least 0.2) in the prior 2 years with the first and last PSA separated by at least 3 months
- Use all values in the last 2 years to calculate PSADT
- PSADT calculated while NOT on androgen deprivation therapy (ADT).
- If prior ADT use, then documented either A) normal testosterone or B) a testosterone within 50 points of normal and stable (defined as a second testosterone at least 6 weeks later that is equal or lower than the first testosterone) is required before starting to calculate PSADT.
- BMI >=24 kg/m2
- Willing to be randomized to a no-diet control or a low-carbohydrate diet
- Reads, writes, and understands English
Exclusion Criteria:
- Anticipate needing secondary prostate cancer therapy within the next 6 months (i.e. radiation, or hormonal therapy)
- Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
- Currently on therapy aimed at lowering testosterone levels (includes gonadotropin-releasing hormone (GnRH) agonist/antagonist, prior bilateral orchiectomy, oral anti-androgens, or 5-alpha reductase inhibitors). Testosterone replacement is allowed but treatment should be stable during the entire study.
- Known distant metastatic disease
- Already consuming a carbohydrate-restricted or vegetarian diet
- Unable or unwilling to adhere to a carbohydrate-restricted dietary intervention
- Weight loss >5% of body weight in the last 6 months
- Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.
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No Intervention: Control
The control arm will receive no dietary intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PSA doubling time (change in PSA over time)
Time Frame: Baseline, 3 and 6 months
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PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization.
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Baseline, 3 and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pao-Hwa Lin, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lin PH, Howard L, Freedland SJ. Weight loss via a low-carbohydrate diet improved the intestinal permeability marker, zonulin, in prostate cancer patients. Ann Med. 2022 Dec;54(1):1221-1225. doi: 10.1080/07853890.2022.2069853.
- Lin PH, Howard L, Freedland SJ. Impact of Low Carbohydrate Diet on Self-Report Fatigue and Weakness in Prostate Cancer Patients. J Urol. 2021 Sep;206(3):499-501. doi: 10.1097/JU.0000000000001780. Epub 2021 Apr 5. No abstract available.
- Freedland SJ, Allen J, Jarman A, Oyekunle T, Armstrong AJ, Moul JW, Sandler HM, Posadas E, Levin D, Wiggins E, Howard LE, Wu Y, Lin PH. A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2). Clin Cancer Res. 2020 Jun 15;26(12):3035-3043. doi: 10.1158/1078-0432.CCR-19-3873. Epub 2020 Feb 27. Erratum In: Clin Cancer Res. 2021 Mar 15;27(6):1823.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2013
Primary Completion (Actual)
August 20, 2018
Study Completion (Actual)
August 20, 2018
Study Registration Dates
First Submitted
December 14, 2012
First Submitted That Met QC Criteria
January 7, 2013
First Posted (Estimate)
January 9, 2013
Study Record Updates
Last Update Posted (Actual)
October 12, 2018
Last Update Submitted That Met QC Criteria
October 10, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00041857
- 1K24CA160653-01A1 (U.S. NIH Grant/Contract)
- 192822 (Other Grant/Funding Number: Atkins Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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