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OpenTrials
Completed

NCT Number: NCT01763944

Carbohydrate Restriction and Prostate Cancer Growth

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.

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Key information

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low carbohydrate diet

Behavioral

The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Cedars-Sinai Medical Center
  • Durham VA Medical Center
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • Robert C. Atkins Foundation

Registry information

Official study title

A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer

Acronym: CAPS2

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jan 9, 2013
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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