Carbohydrate Restriction and Prostate Cancer Growth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-16

Study Completion Date

2018-08-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Low carbohydrate, lifestyle counseling

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

Group Type ACTIVE_COMPARATOR

Low carbohydrate diet

Intervention Type BEHAVIORAL

The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.

Control

The control arm will receive no dietary intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Low carbohydrate diet

The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No