Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carbohydrate restricted diet
Non-restricted diet
Phone counseling with dietitian
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Prostate Adenocarcinoma, Active Surveillance, Diet, Weight Loss, low carb, Ketogenic Diet, Ketogenic
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed prostate adenocarcinoma
- Most recent biopsy positive for prostate cancer
- Currently on or starting active surveillance
- Ability to read, write, and understand English
- BMI >24 kg/m2
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer
- Age > 18 years
Exclusion Criteria:
- Already consuming a severely carbohydrate-restricted (i.e. <20g total carbohydrates per day) or vegetarian diet
- Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
- Anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy)
- Loss of >10% of body weight within the previous 6 months
- Currently receiving any oral hormonal therapy for prostate cancer or BPH (finasteride, dutasteride, bicalutamide)
- If prior oral hormonal therapy use for prostate cancer or BPH (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications)
- Having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (LHRH agonist, LHRH antagonists, ProstVax, Provenge)
- Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.
Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian
Outcomes
Primary Outcome Measures
Mean difference change in proliferative index in prostate cancer patients between carbohydrate restricted diet and non-restricted diet groups from pre-study biopsy (baseline) to 6 months.
Proliferative index is measured by Ki67/apoptosis rate
Secondary Outcome Measures
Mean difference in weight loss before and after intervention between between carbohydrate restricted diet and non-restricted diet groups from baseline to 6 months.
Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 6 months.
AUA intermediate risk is PSA > 10ng/ml or grade group ≥ 2 or clinical stage ≥ T2b
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using EORTC-QLQ-C30.
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IPSS.
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACT-Cog.
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using PROMIS-fatigue.
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACIT-F.
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IIEF-5.
Full Information
NCT ID
NCT03679260
First Posted
September 11, 2018
Last Updated
March 28, 2023
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03679260
Brief Title
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
Official Title
Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 25, 2018 (Actual)
Primary Completion Date
March 24, 2023 (Actual)
Study Completion Date
March 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI >25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Prostate Adenocarcinoma, Active Surveillance, Diet, Weight Loss, low carb, Ketogenic Diet, Ketogenic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian
Intervention Type
Other
Intervention Name(s)
Carbohydrate restricted diet
Intervention Description
20 grams total carbs/day
Intervention Type
Other
Intervention Name(s)
Non-restricted diet
Intervention Description
Subject follows normal diet
Intervention Type
Other
Intervention Name(s)
Phone counseling with dietitian
Intervention Description
Weekly calls with dietitian
Primary Outcome Measure Information:
Title
Mean difference change in proliferative index in prostate cancer patients between carbohydrate restricted diet and non-restricted diet groups from pre-study biopsy (baseline) to 6 months.
Description
Proliferative index is measured by Ki67/apoptosis rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean difference in weight loss before and after intervention between between carbohydrate restricted diet and non-restricted diet groups from baseline to 6 months.
Time Frame
6 months
Title
Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 6 months.
Description
AUA intermediate risk is PSA > 10ng/ml or grade group ≥ 2 or clinical stage ≥ T2b
Time Frame
6 months
Title
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using EORTC-QLQ-C30.
Time Frame
6 months
Title
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IPSS.
Time Frame
6 months
Title
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACT-Cog.
Time Frame
6 months
Title
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using PROMIS-fatigue.
Time Frame
6 months
Title
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACIT-F.
Time Frame
6 months
Title
Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IIEF-5.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed prostate adenocarcinoma
Most recent biopsy positive for prostate cancer
Currently on or starting active surveillance
Ability to read, write, and understand English
BMI >24 kg/m2
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer
Age > 18 years
Exclusion Criteria:
Already consuming a severely carbohydrate-restricted (i.e. <20g total carbohydrates per day) or vegetarian diet
Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
Anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy)
Loss of >10% of body weight within the previous 6 months
Currently receiving any oral hormonal therapy for prostate cancer or BPH (finasteride, dutasteride, bicalutamide)
If prior oral hormonal therapy use for prostate cancer or BPH (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications)
Having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (LHRH agonist, LHRH antagonists, ProstVax, Provenge)
Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Freedland, MD
Organizational Affiliation
Cedars-Sinai Medical Center
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
12. IPD Sharing Statement
Learn more about this trial
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
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