Carbohydrate Restriction and Prostate Cancer Growth

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Low carbohydrate diet

• Registration Number: NCT01763944
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Study Start: 2013-12-16
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-20
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 83

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low carbohydrate, lifestyle counseling	Low carbohydrate diet	The Low carbohydrate arm will receive counseling to follow a carbohydrate restriction diet (\<20 grams per day) for 6 months.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Durham VA Medical Center; 🇺🇸 Durham, North Carolina, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States