Prostate Cancer Clinical Trial
Carbohydrate Restriction and Prostate Cancer Growth
Summary
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.
Eligibility 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
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
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There are 3 Locations for this study
Los Angeles California, 90048, United States
Durham North Carolina, 27702, United States
Durham North Carolina, 27705, United States
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