Carbohydrate Restriction and Prostate Cancer Growth



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:20 - Any
Updated:10/14/2018
Start Date:December 16, 2013
End Date:August 20, 2018

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

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.


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
We found this trial at
3
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Pao-Hwa Lin, PhD
Phone: 919-660-6685
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Stephen J Freedland, MD
Phone: 310-423-0333
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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508 Fulton Street
Durham, North Carolina 27705
919-286-0411
Principal Investigator: Stephen J Freedland, MD
Durham VA Medical Center Since 1953, Durham Veterans Affairs Medical Cetner has been improving the...
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Durham, NC
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