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Carbohydrate Restriction and Prostate Cancer Growth (CAPS2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Duke University
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01763944
First received: December 14, 2012
Last updated: July 22, 2016
Last verified: May 2016
  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
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:


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   (Adult, Senior)
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 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 hormonal therapy
    4. If prior medication usage that alters testosterone level, then documented normal 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763944

Locations
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         
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  192822 
Study First Received: December 14, 2012
Last Updated: July 22, 2016
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 September 26, 2016