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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

83

Study ID:

NCT01763944

Recruitment Status:

Completed

Sponsor:

Duke University

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There are 3 Locations for this study

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Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Duke University Medical Center
Durham North Carolina, 27702, United States
Durham VA Medical Center
Durham North Carolina, 27705, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

83

Study ID:

NCT01763944

Recruitment Status:

Completed

Sponsor:


Duke University

How clear is this clinincal trial information?

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