Carbohydrate Restriction and Prostate Cancer Growth

Prostate Cancer Clinical Trial

— CAPS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763944
• Other study ID #: Pro00041857
• Secondary ID: 1K24CA160653-01A
• Status: Completed
• Phase: N/A
• Start date: December 16, 2013
• Est. completion date: August 20, 2018

Study information

• Verified date: October 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 20, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham VA Medical Center	Durham	North Carolina
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (6)

Lead Sponsor	Collaborator
Duke University	Cedars-Sinai Medical Center, Durham VA Medical Center, National Cancer Institute (NCI), National Institutes of Health (NIH), Robert C. Atkins Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA doubling time (change in PSA over time)	PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization.	Baseline, 3 and 6 months