search
Back to results

Carbohydrate Restriction and Prostate Cancer Growth (CAPS2)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low carbohydrate diet
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring diet, prostate cancer, carbohydrate, lifestyle

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Duke University Medical Center
  • Durham VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Low carbohydrate, lifestyle counseling

Control

Arm Description

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

The control arm will receive no dietary intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2012
Last Updated
October 10, 2018
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI), Robert C. Atkins Foundation, Cedars-Sinai Medical Center, Durham VA Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01763944
Brief Title
Carbohydrate Restriction and Prostate Cancer Growth
Acronym
CAPS2
Official Title
A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 16, 2013 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI), Robert C. Atkins Foundation, Cedars-Sinai Medical Center, Durham VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
diet, prostate cancer, carbohydrate, lifestyle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low carbohydrate, lifestyle counseling
Arm Type
Active Comparator
Arm Description
The Low carbohydrate arm will receive counseling to follow a carbohydrate restriction diet (<20 grams per day) for 6 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control arm will receive no dietary intervention.
Intervention Type
Behavioral
Intervention Name(s)
Low carbohydrate diet
Intervention Description
The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.
Primary Outcome Measure Information:
Title
PSA doubling time (change in PSA over time)
Description
PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization.
Time Frame
Baseline, 3 and 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pao-Hwa Lin
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27702
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35486445
Citation
Lin PH, Howard L, Freedland SJ. Weight loss via a low-carbohydrate diet improved the intestinal permeability marker, zonulin, in prostate cancer patients. Ann Med. 2022 Dec;54(1):1221-1225. doi: 10.1080/07853890.2022.2069853.
Results Reference
derived
PubMed Identifier
33819069
Citation
Lin PH, Howard L, Freedland SJ. Impact of Low Carbohydrate Diet on Self-Report Fatigue and Weakness in Prostate Cancer Patients. J Urol. 2021 Sep;206(3):499-501. doi: 10.1097/JU.0000000000001780. Epub 2021 Apr 5. No abstract available.
Results Reference
derived
PubMed Identifier
32108029
Citation
Freedland SJ, Allen J, Jarman A, Oyekunle T, Armstrong AJ, Moul JW, Sandler HM, Posadas E, Levin D, Wiggins E, Howard LE, Wu Y, Lin PH. A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2). Clin Cancer Res. 2020 Jun 15;26(12):3035-3043. doi: 10.1158/1078-0432.CCR-19-3873. Epub 2020 Feb 27. Erratum In: Clin Cancer Res. 2021 Mar 15;27(6):1823.
Results Reference
derived

Learn more about this trial

Carbohydrate Restriction and Prostate Cancer Growth

We'll reach out to this number within 24 hrs