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Carbohydrate Restriction and Prostate Cancer Growth (CAPS2)

This study is currently recruiting participants.
Verified April 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763944
First Posted: January 9, 2013
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Robert C. Atkins Foundation
Cedars-Sinai Medical Center
Durham VA Medical Center
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention
Prostate Cancer Behavioral: Low carbohydrate diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

    1. 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
    2. Use all values in the last 2 years to calculate PSADT
    3. PSADT calculated while NOT on androgen deprivation therapy (ADT).
    4. 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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Dana Levin, MPH    310-423-0333    Dana.Levin@cshs.org   
Principal Investigator: Stephen J Freedland, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27702
Contact: Pao-Hwa Lin, PhD    919-660-6685    pao.hwa.lin@dm.duke.edu   
Principal Investigator: Pao-Hwa Lin, PhD         
Durham VA Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Rebecca Turner    919-286-0411 ext 5074    Rebecca.Turner28@va.gov   
Contact: Jamie Michael    919-286-0411 ext 5105    Jamie.Michael2@va.gov   
Principal Investigator: Stephen J Freedland, MD         
Sponsors and Collaborators
Duke University
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Robert C. Atkins Foundation
Cedars-Sinai Medical Center
Durham VA Medical Center
Investigators
Principal Investigator: Pao-Hwa Lin Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01763944     History of Changes
Other Study ID Numbers: Pro00041857
1K24CA160653-01A1 ( U.S. NIH Grant/Contract )
192822 ( Other Grant/Funding Number: Atkins Foundation )
First Submitted: December 14, 2012
First Posted: January 9, 2013
Last Update Posted: August 22, 2017
Last Verified: April 2017

Keywords provided by Duke University:
diet
prostate cancer
carbohydrate
lifestyle

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases