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Carbohydrate Restriction and Prostate Cancer Growth (CAPS2)

This study is not yet open for participant recruitment.
Verified January 2013 by Duke University
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01763944
First received: December 14, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  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 Phase
Prostate Cancer
 Behavioral: Low carbohydrate diet
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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: December 2016
Estimated Primary Completion Date: December 2016 (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

Ages Eligible for Study:   20 Years and older
Genders 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 3 and 10 ng/ml

  • PSA doubling time (PSADT) >3 months and <24 months

    1. Calculated based at least 2 values 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 hormonal therapy
    4. If prior hormonal therapy use, then documented normal testosterone is required before starting to calculate PSADT
  • BMI >25 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 altering testosterone levels (includes gonadotropin-releasing hormone (GnRH) agonist/antagonist, prior bilateral orchiectomy, oral anti-androgens, or 5-alpha reductase inhibitors)
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763944

Sponsors and Collaborators
Duke University
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Pao-Hwa Lin Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01763944     History of Changes
Other Study ID Numbers: Pro00041857, 1K24CA160653-01A1
Study First Received: December 14, 2012
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013