Prostate Cancer
Conditions
Keywords
diet, prostate cancer, carbohydrate, lifestyle
Brief 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.
Interventions
BEHAVIORALLow carbohydrate diet
The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Robert C. Atkins Foundation
Cedars-Sinai Medical Center
Durham VA Medical Center
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
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 androgen deprivation therapy (ADT). 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA doubling time (change in PSA over time) | Baseline, 3 and 6 months | PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization. |
Countries
United States
Outcome results
None listed