Carbohydrate Restriction and Prostate Cancer Growth

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01763944

Run by

Duke University

People needed

83

Starts

2013-12-16

Expected to finish

2018-08-20

Last updated by the study team

2018-10-12

Who can join

Age: 20 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Durham VA Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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