Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Duke University
With
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Robert C. Atkins Foundation
Cedars-Sinai Medical Center
Durham VA Medical Center
Age
20–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible 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
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
You may not be 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
Clareo Health | Carbohydrate Restriction and Prostate Cancer Growth
